Translating an Evidence-based Multicomponent Intervention for Older Adults With Dementia and Caregivers

Abstract

Background and Objectives

Effective community-based programs to maintain health and well-being of adults with dementia are needed. This article describes the translation, implementation, and effectiveness of a multicomponent exercise plus behavioral/psychosocial intervention (Reducing Disability in Alzheimer’s Disease-NorthWest [RDAD-NW]) conducted by staff in regional Area Agencies on Aging (AAAs).

Research Design and Methods

Staggered multiple baseline design was used; 10 AAAs, 20 case managers, and 255 community-residing persons with dementia (PWDs), and family caregivers were enrolled. RDAD-NW was conducted in-home over 6 weeks with aerobic/endurance, strength, and balance/flexibility exercises, dementia education, training to increase pleasant events, and activator-behavior-consequence problem-solving approach. Outcomes included case manager treatment fidelity, and caregiver/PWD physical activity, restricted activity days, physical functioning, quality of life, and affect.

Results

RDAD-NW was successfully translated and implemented by AAA agency staff through their usual service provision mechanisms. Staff responded positively and delivered the program with a high degree of fidelity. Caregiver/PWD dyads also responded favorably engaging in both exercise and behavioral/psychosocial portions of the program. A total of 207 dyads (81%) completed the intervention and 140 (55%) completed the 13-month follow-up. PWD physical activity increased significantly pre- to posttreatment (p < .001, ES = .54), and 13 months (p < .01, ES = .21). Quality of life of PWD increased significantly pre- to posttreatment (p < .001, ES = .29); caregiver depression improved pre- to posttreatment (p = .01, ES = −.18).

Discussion and Implications

RDAD-NW was successfully translated and implemented by AAA case managers and resulted in increased physical activity and improved behavioral and emotional outcomes of caregiver/PWDs. Results support continued dissemination and implementation of RDAD-NW.

Clinical Trials Registration

NCT01708304

Dementia is projected to affect an estimated 13.8 million people in the United States by the year 2050 (a 300% increase over current numbers) (Hebert, Weuve, Scherr, & Evans, 2013). It is currently the fifth leading cause of death of individuals over age 65 (Murphy, Kochanek, Xu, & Heron, 2015) and is associated with increased medical morbidity, medication use, hospitalizations, health care utilization, and nursing home admission (Arrighi, Neumann, Lieberburg, & Townsend, 2010; Institute of Medicine, 2008; Kramarow, Lubitz, Lentzner, & Gorina, 2007). Most of these individuals are cared for in the community by family members or other unpaid caregivers, about one-third of whom are themselves over age 65 (Alzheimer’s Association, 2016). Caring for a person with dementia (PWD) is associated with declines in both physical and psychological health of the caregiver, and for some individuals, may increase risk of mortality (Schulz & Beach, 1999). Effective community-based programs to maintain the health and well-being of older adults with dementia and their caregivers could help mitigate or prevent excess disability associated with this debilitating and progressive disease.

The need for translational evidence-based research to bring social and behavioral scientific advances into the community to enable existing community agencies and networks to maintain the health, and independence of older adults has received increasing attention (Livingston et al., 2017; Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014). Accumulating evidence supports the efficacy of non-pharmacological approaches to alleviating the problems experienced by older adults with dementia and their family caregivers (Teri, McKenzie, & Coulter, 2016), and the importance of physical activity among frail individuals of advanced age (Puts et al., 2017) including individuals with cognitive impairment (Teri, McCurry, Logsdon, & McGough, 2014), Despite this, few such programs have been successfully applied by community-based agencies (Gitlin, Marx, Stanley, & Hodgson, 2015) and none, to date, combine both non-pharmacological dementia-care problem solving and exercise. Indeed, a recent comprehensive review of psychosocial interventions for dementia concluded: “Most of the programs found to be effective in research trials have been tested outside of existing care systems therefore the feasibility of providing the programs in routine service delivery is unclear” (Clemson et al., 2018).

This article describes the translation and implementation of an evidence-based multicomponent exercise plus behavioral/psychosocial intervention for older adults with dementia and their family caregivers: Reducing Disability in Alzheimer’s Disease (RDAD; Teri et al., 2003). This translational investigation (now referred to as RDAD-NW) was a collaboration between the original research team, the Oregon Department of Health, the Washington Department of Aging and Disability Services, and 10 Area Agencies on Aging (AAAs).

RDAD-NW is grounded in behavioral and gerontological theory (Teri, Logsdon, & McCurry, 2005), using a structured problem-solving process to: train family caregivers to guide the PWD through a structured exercise program (Logsdon, McCurry, & Teri, 2005; Teri, Logsdon, & McCurry, 2008), address behavioral issues that occur throughout the course of the disease, and increase engagement in events that the PWD enjoys (Teri & Uomoto, 1991). The RDAD-NW protocol uses a goal-directed approach to provide easy-to-implement strategies for caregivers and care-receivers to facilitate regular participation in structured and unstructured physical activity. At the foundation of this multicomponent translational intervention is the following: (i) education and goal-setting, including ways to compensate for common dementia-related impairments, (ii) a sequential progression of evidence-based exercises known to improve strength and mobility in older adults, and (iii) behavioral interventions incorporating social support, pleasant events and the well-established A-B-C (activator-behavior-consequence) behavioral problem-solving approach to behavior management (Teri et al., 2005). The A-B-C approach teaches caregivers behavioral principles for identifying and decreasing triggers and reinforcers of negative behaviors (including depressive behaviors and inactivity) while at the same time providing opportunities and encouragement for positive, pleasant activities and interactions (including physical activity, social interactions, and other pleasant events); using A-B-Cs helps caregivers make exercise enjoyable for the PWD and promotes sustained increases in physical activity (Teri et al., 2008).

RDAD was originally developed and tested in a randomized clinical trial (RCT) with 153 community-residing older adults with dementia and their family caregivers (Teri et al., 2003). At posttreatment, RDAD subjects exercised significantly more than those receiving routine medical care (odds ratio 2.82, 95% CI: 1.22 to 6.49, p = .01), had fewer restricted activity days (odds ratio 3.10, 95% CI: 1.08 to 8.95, p < .001), and improved on physical function (mean SF-36 Physical Role Functioning difference score 19.29, 95% CI: 8.75 to 29.83, p < .001). Furthermore, at the 12-month follow-up assessment, RDAD subjects were less likely to be institutionalized due to behavioral disturbances (Teri et al., 2003) This empirical demonstration that the combination of exercise with evidence-based behavioral problem-solving was effective in reducing excess disability and improving the physical function of PWDs and was effective in training caregivers to cope more effectively with behavioral disturbances, makes RDAD unique among non-pharmacological interventions for dementia. As a testament to the methodological rigor and clinical sophistication of this program, RDAD was recognized by the Rosalynn Carter Institute for Caregiving (Rosalynn Carter Institute for Caregiving 2017). Thus, RDAD was primed for translation into the community.

Objective

This investigation evaluated (i) the translation and implementation of RDAD-NW by AAA case workers and (ii) the effectiveness of this translation on outcomes of physical activity, mood, and quality of life among community-residing older adults with dementia and their caregivers. It was hypothesized: (i) that AAA staff would be successful in implementing RDAD-NW and (ii) (consistent with findings from the original RDAD RCT) that participants (both PWD and caregivers) enrolled in RDAD-NW would show significant pre- to posttreatment improvements, compared to a 1-month baseline period, and that these improvements would be maintained at 13 months. The University of Washington Institutional Review Board approved the study.

Methods

Design

A staggered multiple baseline design (Hawkins, Sanson-Fisher, Shakeshaft, D’Este, & Green, 2007) offered a number of advantages for this translational investigation (Mercer, DeVinney, Fine, Green, & Dougherty, 2007). First, AAAs were randomized in 3-month intervals for time of implementation of the intervention (staggered design across 1 year) increasing confidence that the intervention (and not time-related variables) was responsible for observed outcomes. Second, once the intervention was implemented, this design allowed each AAA to enroll participants in a manner consistent with their standard enrollment procedures for other programs. Third, an initial no-treatment baseline period allowed dyads to act as their own control up to the time when they began the RDAD-NW intervention. Thus, the design was both practical and methodologically rigorous for the evaluation of the RDAD-NW study, allowing the flexibility necessary to conduct a truly translational project while ensuring the methodological rigor necessary for translation science.

Setting

Ten AAAs representing a mixture of urban (n = 4) and rural (n = 6) locations across two states participated in the investigation, with agency supervisory staff trained to oversee the program, and at least two case managers from each AAA trained as RDAD-NW coaches. The AAAs negotiated individual contracts with the research team, receiving a per-client fee for providing the program to recover costs for case manager time and travel (for home visits), as well as supervisory costs.

Coaches

All coaches were AAA case managers or counselors with experience in family caregiver support programs who agreed to participate in all phases of the RDAD-NW program. A minimum of two coaches at each AAA were trained.

Expert Trainers

University of Washington researchers who developed and conducted the original RDAD trial trained coaches and oversaw implementation (co-authors Teri, Logsdon, and McCurry were all involved in the original RDAD trial).

Training and Fidelity

Following well-established frameworks for translational research (such as Behavior Change Consortium [Bellg et al., 2004]), RDAD-NW adhered to the original RDAD intervention in a number of ways. First, training was conducted using standardized and previously tested materials (manuals, handouts, tracking systems, etc.) that maintained and explained the theoretical background of RDAD, assured that the core content was covered, and established a standardized number of contact hours to be spent with caregivers and PWDs. Second, providers were given standardized training, covering each of the core areas and providing time to enact situations and practice their skills. Third, treatment fidelity was measured both in terms of delivery (ensuring providers delivered RDAD-NW as intended, used the manual, followed the protocol) and treatment receipt (establishing that both providers, caregivers and PWDs (when reasonable, based on their level of impairment) understood the key principles taught and were successful in performing the necessary skills.

Consistent with translational research goals, RDAD-NW also had to meet the challenges of the partnering agencies. To this end, we streamlined provider training, shortened the number of sessions providers spent in-home with caregivers and PWDs, and simplified forms completed by the providers. These changes were relatively minor yet were responsive to the staffing and funding needs of the AAAs. We also routinely met with AAA agency staff and administration to insure the program was running well and to make any adjustments that were needed.

RDAD-NW used a detailed treatment manual adapted and updated from the original RCT, including instructions, graphic illustrations of the exercises, handouts, and process/fidelity forms. (The original RDAD manual plus the updated RDAD-NW manual and training DVD are available from the first author.) Coaches were trained in a structured, 2-day workshop followed by at least one closely supervised training case, in which all sessions were audio-recorded and rated by experts regarding adherence to the treatment protocol, competence delivering exercise and behavior management instructions, problem-solving abilities, and general therapeutic skill. Once each coach successfully completed a case, expert trainers continued to review audiotapes of randomly selected sessions to monitor maintenance of treatment fidelity throughout the course of the program.

RDAD-NW Protocol

The actual content and contact time of the program was unchanged from the original protocol. The exercise component of RDAD included aerobic/endurance activities, lower-body strength training, and exercises to improve balance and flexibility. Exercises were introduced incrementally and individualized to meet the needs of each person. Each exercise was first demonstrated by the coach, then practiced by the PWD and caregiver. Coaches monitored the exercises closely to ensure that they were practiced safely and correctly. Caregivers and PWDs practiced the exercises at each session, and coaches encouraged dyads to engage in a minimum of 30 min of moderate-intensity exercise (usually walking) every day, with more frail individuals starting out for shorter periods of time and increasing gradually over the course of treatment. Caregivers learned to guide PWDs in each component of exercise allowing the exercises to be tailored to the unique physical, cognitive, and behavioral status of the PWD (Logsdon et al., 2005; Teri et al., 1998).

The behavioral/psychosocial problem-solving component of RDAD used systematic methods to train caregivers to identify and alleviate PWD behavioral problems that could impair day-to-day function, adversely affect caregiver/PWD interactions, and interfere with exercise participation. Caregivers were taught a set of core behavioral strategies that include dementia education, training in effective communication, A-B-C problem-solving strategies, use of pleasant events to reduce dementia-related mood and behavioral disturbances, and assistance in strategies to improve their own emotional well-being and reduce their reactions to challenging behaviors (Teri et al., 2008). Caregivers were also encouraged to identify pleasant activities that could be incorporated into the exercise program and use each of the strategies mentioned above to aid in exercise compliance. Finally, caregiver issues, such as depression, burden, and stress, were assessed and sources of support were identified.

The RDAD protocol was intentionally developed to allow coaches some flexibility in delivery, based on the needs of individual dyads. For example, coaches could introduce focused discussion on caregiver issues (e.g., depression or need for respite assistance) earlier in the program if they were impacting implementation of the exercise training components. Coaches completed session progress notes and content checklists to ensure that all components of the intervention were completed during the treatment period. Such modifications were rare, and were discussed with UW expert trainers when they occurred.

Participants

A total of 255 older adults (60+ years) with dementia who were living in the community and their family caregivers were identified from the caseloads of collaborating AAAs (including both preexisting clients and new clients who contacted or were contacted by the AAA during the investigation). All participants were initially contacted, screened, consented, and enrolled by trained intake workers.

Eligibility criteria were designed to insure participants were representative of clients ordinarily served by the AAAs, and to establish a sustainable method for ongoing case ascertainment and enrollment for the AAAs. Eligible PWDs were 60 years of age and older and had a diagnosis of dementia from a primary care physician, confirmed by their caregiver. Caregivers were required to live in the community and provide daily care to the participating PWD. Participants were excluded if: they had plans to move within 4 months of enrollment; the PWD was already participating in a formal exercise program or engaging in at least 150 min a week of moderate-intensity physical activity; either the PWD or caregiver had medical or psychiatric conditions that would influence participation in or outcomes of the exercise program (e.g., Parkinson’s disease, Huntington’s disease, traumatic brain injury or stroke with persistent muscle weakness; recent psychiatric hospitalization; active suicidal thoughts, hallucinations, or delusions; uncorrected severe visual or hearing impairments; or inability to walk).

Measures

Primary effectiveness/outcome measures were consistent with those collected as part of the original RDAD RCT: physical activity, including exercise days (number of days/week of at least 30 min of physical activity), percent of participants who exercised at least 60 minutes/week (=2 or more days with ≥ 30 min), and functional status (restricted activity days). Secondary outcomes included physical activity of caregivers, physical functioning, and physical role functioning (SF-36) of PWDs and caregivers, quality of life (QOL-AD) of PWDs, and affect (center for epidemiologic studies depression scale) of caregivers. All measures were administrated to caregivers over the telephone by experienced research interviewers to ensure maximal flexibility for evaluating participants across the two-state rural/semi-rural/urban area. Telephonic interviews lasted about 40 min and caregivers received a mailed documentation in advance to facilitate the interview.

Statistical Analyses

For the second goal of this study, evaluation of treatment outcomes, the study was designed to have 80% power (α = .05, two-sided) to detect effect sizes of 0.2 standard deviations for number of restricted activity days and to detect a 10% difference in the percentage of PWDs exercising ≥ 60 min/week from an expected value of 56% estimated from the original RDAD randomized trial (Teri et al., 2003).

All analyses were based on intention-to-treat principles, using all dyads enrolled in the study. Outcomes for PWDs and caregivers were assessed using longitudinal mixed-effects regression models (Blackwell, de Leon, & Miller, 2006). All models included time, treated as a categorical variable, and baseline scores of the outcome models as fixed effects. The models also included random intercepts for each participant to account for the dependence of scores across time. Count data were modeled with either negative binomial or Poisson regression. PWD exercise days were modeled with a repeated measures negative binominal regression model with a random intercept because there was both a preponderance of zeros and evidence of over-dispersion. Caregiver exercise days did not show evidence of over-dispersion and were modeled with a repeated measures Poisson regression model with a random intercept. Mixed-effects logistic regression models were estimated for binary outcomes and continuous outcomes were estimated with mixed-effects linear regression models. For all models, conclusions about effectiveness and maintenance were based on comparisons of outcomes estimated with appropriate contrasts from the longitudinal model.

Adjusted models examined whether effects of the intervention were moderated by age, sex, PWD cognitive impairment, and urban or rural location of the AAA. These analyses included terms for the interaction of time and the moderating effect. As with the primary outcome analyses, conclusions about possible moderating effects were based on contrasts from the longitudinal model with the appropriate functional form. The effect sizes were calculated as the mean difference between assessment points divided by the standard deviation of the differences. All analyses were conducted using Stata version 14.2 (StataCorp). All hypothesis tests were two-tailed with p < .05 considered significant. No adjustment was made for multiple comparisons.

Results

Translation and Implementation of RDAD-NW by AAAs

Fidelity Assessment

Individual AAA coaches each saw an average of 10.5 (SD = 9.5) dyads (range 1–33); dyads completed an average of 8.9 sessions (range 6–9). There were no significant differences between AAAs in the number of treatment dropouts or number of completed sessions. The average RDAD-NW treatment session was 58.8 min (SD = 19.1). On the basis of supervisor audio reviews, coach adherence to RDAD-NW protocol content across sessions averaged 82%–94% with dyads engaged in assigned homework 91% of the time. Coaches also rated the program highly; balance/flexibility (81%) and strength training (75%) were rated the most helpful exercise components; caregiver support (87%), education about realistic expectations (82%) encouraging pleasant events (80%) and learning A-B-Cs (73%) were rated the most helpful psychosocial components.

Caregiver/PWD dyads: 255 dyads were enrolled, with 207 dyads completing the RDAD-NW intervention and 3-month posttreatment assessment, for a retention rate of 81%. Of them, 140 dyads (55%) completed the 13-month follow-up. We compared demographic and baseline characteristics for those completing the intervention with those who dropped out. PWDs who dropped out reported lower quality of life (−2.0, [95% CI: −3.8 to 0.1], p = .04) and caregivers who dropped out were more depressed (−3.1, [95% CI: 0.2 to 5.9], p = .04). No other variables were related to intervention dropout. Figure 1 illustrates the flow of dyads through the study. An average of 25.2 (SD = 23.8) dyads were enrolled by each AAA (range 8–88).

Figure 1.

Flow of PWDs and Caregivers Through the Study

Comparison between original RDAD and RDAD-NW: Because one goal of this study was to investigate the translation of a former RCT protocol, we compared demographic characteristics between participants in the current trial (RDAD-NW) to those in the original RCT (RDAD). RDAD-NW PWDs were slightly older than RDAD PWDs (81.3 years vs. 77.8 years, 3.5, [95% CI: 2.0 to 5.0], p < .001). RDAD-NW caregivers were more likely to be an adult child (29% vs. 5%, p < .001). Other demographics were similar between the two studies. Baseline characteristics of RDAD-NW participants are provided in Table 1.

Table 1.

Baseline Characteristics of Reducing Disability in Alzheimer’s Disease-NorthWest Participants

	Mean (SD) (n = 255)
Characteristic	Persons w/dementia	Caregivers
Age (year)
Mean (SD)	81.3 (7.7)	68.7 (12.4)
Median (IQR)	81.5 (75.7–87.0)	70.3 (60.0–77.7)
Range	(60–97)	(29–94)
Female, no. (%)	125 (49.0)	190 (74.5)
White, no. (%)	228 (89.4)	224 (87.8)
Educational status (≥ high school), no. (%)	167 (65.5)	193 (75.7)
Caregiving relationship, no. (%)
Spouse		161 (63.1)
Adult child		74 (29.0)
Mini-mental state examinationa
Mean (SD)	15.6 (7.1)
Median (IQR)	16 (11–21)
Number of medical conditions limiting activity
Mean (SD)	2.1 (1.4)	2.0 (1.5)
Median (IQR)	2 (1–3)	2 (1–3)
Range	(0–7)	(0–7)
Fall in last 6 weeks, no. (%)	11 (4.3)	0 (0.0)
Days exercise ≥ 30 min, past week
Mean (SD)	1.4 (1.9)	2.9 (2.6)
Median (IQR)	0 (0–2)	3 (0–5)
Exercise ≥ 60 min past week, no. (%)	91 (35.7)	156 (61.2)
Restricted activity days ≥ 1, past 2 weeks, no. (%)	21 (8.2)	43 (16.9)
SF-36 scoresb
Physical functioning	43.0 (30.1)	75.5 (26.0)
Physical role functioning	58.1 (37.0)	71.5 (37.9)
CES-Dc		12.9 (9.1)
Revised memory and behavior problem checklistd
Memory subscale	2.9 (0.7)
Depression subscale	1.5 (0.4)
Disruption subscale	1.4 (0.4)
Caregiver reaction total		0.7 (0.5)
Quality of life in Alzheimer’s diseasee	31.4 (6.0)

Note: IQR, interquartile range.

^aValues range from 0 to 30, with higher values indicating less cognitive impairment.

^bThe 36-Item Short Form Health Survey (SF-36) scores range from 0 to 100, with higher scores representing better health status.

^cThe Center for Epidemiological Studies-Depression (CES-D) scores range from 0 to 60, with higher scores indicating greater depression.

^dThe Revised Memory and Behavior Problem Checklist scores range from 0 to 4, with higher scores representing more frequent problems.

^eHigher Quality of Life in Alzheimer’s Disease scores range from 0 to 52, higher scores indicate better quality of life.

Effectiveness of This Translation

Participant Outcomes

Study outcomes for the staggered multiple baseline design, including those for the pretreatment baseline period, the pre- to posttreatment intervention period, and the follow-up assessment period (pretreatment to 7- and 13-month follow-up) are shown in Table 2. As expected, no significant changes were found during the control assessment (between baseline and pretreatment) on any PWD or caregiver outcomes (Tables 2 and 3). Primary assessment study outcomes are for the period from pretreatment to posttreatment; follow-up assessments from pretreatment to 13 months.

Table 2.

Reducing Disability in Alzheimer’s Disease-NorthWest Outcomes for persons with dementia and Caregivers

			Mean (SE) (95% CI) change from
	Mean (SE)(95% CI)	Control assessment			Primary assessment		Follow-up assessment
Variable (range of possible values)	Baseline	Baseline to pretreatment		p Value	Pretreatment to posttreatment	p Value	Pretreatment to 13 months	p Value
Days exercise ≥ 30 min (0–7)a
persons with dementia	1.59 (0.15) (1.31 to 1.88)	0.06 (0.10) (−0.13 to 0.25)		.53	0.58 (0.09) (0.40 to 0.75)	<.001	0.28 (0.11) (0.07 to 0.49)	.01
Caregiver	2.89 (0.13) (2.63 to 3.14)	0.07 (0.05) (−0.04 to 0.17)		.21	0.21 (0.05) (0.11 to 0.31)	<.001	0.03 (0.06) (−0.09 to 0.15)	.66
Exercise ≥ 60 min past week (0/1)b
persons with dementia	0.36 (0.03) (0.31 to 0.41)	0.35 (0.24) (−0.12 to 0.83)		.15	1.43 (0.26) (0.92 to 1.93)	<.001	0.60 (0.28) (0.05 to 1.15)	.03
Caregiver	0.62 (0.02) (0.57 to 0.67)	0.36 (0.25) (−0.14 to 0.86)		.15	1.16 (0.29) (0.59 to 1.73)	<.001	−0.09 (0.31) (−0.69 to 0.51)	.77
Restricted activity days ≥ 1 past two weeks (0/1) b
persons with dementia	0.08 (0.02) (0.05 to 0.12)	0.70 (0.33) (0.06 to 1.34)		.03	0.06 (0.30) (−0.54 to 0.65)	.85	0.39 (0.33) (−0.26 to 1.04)	.24
Caregiver	0.17 (0.02) (0.12 to 0.22)	0.06 (0.26) (−0.45 to 0.58)		.81	0.00 (0.28) (−0.54 to 0.54)	.99	0.32 (0.30) (−0.27 to 0.91)	.29
SF-36 Physical Functioning (0–100)c, d
persons with dementia	44.53 (0.87) (42.88 to 46.24)	−0.46 (1.07) (−2.55 to 1.63)		.67	0.64 (1.13)(−1.57 to 2.84)	.57	−10.35 (1.28)(−12.87 to −7.83)	<.001
Caregiver	76.93 (0.69) (75.58 to 68.27)	−1.17 (0.82) (−2.77 to 0.43)		.15	−0.00 (0.86)(−1.69 to 1.68)	.99	−0.67 (0.99)(−2.60 to 1.26)	.50
SF-36 Physical Role Functioning (0–100)c, d
persons with dementia	59.16 (1.99) (55.27 to 63.06)	−1.86 (2.65) (−7.08 to 3.31)		.48	−2.19 (2.80)(−7.67 to 3.29)	.43	−13.57 (3.17)(−19.79 to −7.35)	<.001
Caregiver	71.43 (1.83) (67.84 to 75.01)	−0.51 (2.39) (−5.19 to 4.17)		.83	−2.39 (2.52)(−7.33 to 2.55)	.34	−4.01 (2.87)(−9.64 to 1.63)	.16
CES-D (0–60)c,e
Caregiver	12.66 (0.34) (11.98 to 13.33)	−0.27 (0.42) (−1.10 to 0.56)		.52	−1.15 (0.45)(−2.03 to 0.28)	.01	0.22 (0.51)(−0.79 to 1.22)	.67
Quality of life-AD (0–52)c, f
persons with dementia	31.82 (0.21)(31.40 to 32.23)	−0.27 (0.26)(−0.77 to 0.24)		.30	1.03 (0.27)(0.50 to 1.56)	<.001	−0.17 (0.31)(−0.78 to 0.44)	.59

^aEstimates for exercise days from repeated measures, negative binomial regression model with a random intercept for care-recipients to persons with dementia; Poisson model with a random intercept for caregivers.

^bEstimates from repeated measures, mixed effects logistic regression model with a random intercept.

^cEstimates from repeated measures, mixed effects linear regression model with a random intercept.

^dHigher scores on the 36-Item Short Form Health Survey (SF-36) indicate better health status.

^eHigher scores on the Center for Epidemiological Studies-Depression indicate greater depression.

^fHigher scores on the Quality of Life in Alzheimer’s Disease (AD) indicate better quality of life.

Table 3.

Reducing Disability in Alzheimer’s Disease-NorthWest Intervention Effects for Exercise Days Adjusted for Site Location, Age, Sex, and MMSE

		Mean (SE) (95% CI) change from
	Mean (SE)(95% CI)	Control assessment		Primary assessment		Follow-up assessment
Variable	Baseline	Baseline to Pretreatment	p Value	Pretreatment to Posttreatment	p Value	Pretreatment to 13 months	p Value
Persons with dementiaa
Urban AAAb	1.57 (0.19)(1.21 to 1.94)	0.15 (0.19)(−0.22 to 0.53)	.42	0.06 (0.18)(−0.29 to 0.41)	.74	0.33 (0.22)(−0.10 to 0.75)	.13
Age ≥ 80 year	1.35 (0.16)(1.04 to 1.67)	−0.20 (0.19)(−0.58 to 0.18)	.31	0.24 (0.18)(−0.11 to 0.59)	.18	0.28 (0.22)(−0.14 to 0.71)	.19
Men	1.74 (0.19)(1.37 to 2.12)	−0.03 (0.19)(−0.41 to 0.35)	.88	−0.13 (0.18)(−0.49 to 0.22)	.45	−0.46 (0.21) (−0.88 to −0.05)	.03
MMSE ≥ 16	1.51 (0.18)(1.16 to 1.85)	0.17 (0.19)(−0.20 to 0.55)	.37	−0.02 (0.18)(−0.37 to 0.33)	.91	0.18 (0.22)(−0.24 to 0.60)	.40

Note: MMSE, mini-mental state examination; AAA, area agencies on aging.

^aEstimates for exercise days from repeated measures, negative binomial regression model with a random intercept.

^bReferent group is rural AAA.

The primary physical activity outcome, exercise days (number of days walking or other aerobic exercise for at least 30 min; illustrated in Figure 2) increased significantly from pre- to posttreatment for both PWDs (0.58, [95% CI: 0.40 to 0.75], p < .001) and caregivers (0.21, [95% CI: 0.11 to 0.31], p < .001) and remained significant at 13 months for PWDs (0.28, [95% CI: 0.07 to 0.49], p = .01) but not for caregivers. As shown in Table 3, the primary outcome of exercise days for the PWD was not affected by site location (rural vs. urban), mini-mental state examination, or age, but male participants were less likely than female participants to continue exercising at the same level at the 13-month follow-up (−0.46, [95% CI: −0.88 to 0.05], p = .03).

Figure 2.

Exercise Days for PWDs and Caregivers

The primary functional status outcome, Restricted Activity Days, was unchanged for either PWD or caregiver at posttreatment or follow-up. For secondary outcomes, quality of life of PWDs increased significantly from pre- to posttreatment (1.03, [95% CI: 0.50 to 1.56], p < .001) and caregiver depression decreased from pre- to posttreatment (−1.15, [95% CI: −2.03 to −0.28], p = .01); neither improvement was maintained at follow-up. Neither the physical function nor physical role function of the SF-36 improved with treatment.

Discussion

This investigation represents one of the first well-designed translational studies of an evidence-based multicomponent exercise plus behavioral/psychosocial intervention to improve health and well-being of PWDs and their family caregivers. RDAD-NW (Reducing Disability in Alzheimer’s Disease-NorthWest translation program) was conducted in community settings within a menu of services provided by Area AAA, primary providers of older adult services in their communities. Caregiver/PWD dyads were enrolled by AAA providers, using their standard procedures, to identify appropriate candidates for the program with minimal assistance from the research team.

RDAD-NW was designed to include all components and content of the original RDAD intervention, whereas providing flexibility needed to facilitate delivery within the case management programs across rural and urban settings. Using principles of social and behavioral theory, with an understanding of disease-related pathology and impairments, RDAD-NW provides a vehicle to effectively increase physical activity in community-dwelling older adults with dementia and their caregivers. A recent systematic review reported that goal setting, social support and using a credible source, key components of the RDAD-NW intervention, are promising approaches to increasing physical activity among people with dementia (Nyman, Adamczewska, & Howlett, 2018) providing support for the mechanism in which behavior change is accomplished in this population. AAAs responded positively to this procedure and delivered the program with a high degree of fidelity. Caregiver and PWD dyads also responded favorably to the program, engaging in both components of the program (exercise and behavioral/psychosocial), and coaches rated both components highly in degree of helpfulness.

Consistent with the original RCT, significant improvements in exercise participation for the PWD and improvements in caregiver depression were obtained. New findings from this study (not collected in the original RCT) were the significant improvement in the quality of life for the PWD and increased engagement in exercise for the caregiver. This provides even more support for the positive impact of this intervention. In contrast to the original RDAD RCT, no improvement in subscales of the SF-36 were obtained. This may be due to the fact that PWDs in this study were slightly older and more cognitively impaired than those in the original investigation. Given this, the positive findings obtained are even more striking.

The positive response of the AAA staff and participant dyads further support the utility of disseminating and implementing RDAD-NW. Engaging in this program was challenging for some participating agencies. Some AAAs had more difficulty identifying appropriate participant dyads than others. Additional challenges included understanding the constraints of a research protocol and adhering to the time schedule of sessions to facilitate standardized assessment intervals. RDAD-NW was only one of a number of caregiver services offered by participating AAAs and coaches had to prioritize time and travel across their multiple competing responsibilities. Our experience was that coaches were more successful when they had strong administrative support for the program within their agency. In those situations, once the rationale for research-specific requirements was clear, agencies were able to conduct the program in a way that was consistent with their policies and preferences.

There were, of course, bumps in the road to this successful translation. First, as already mentioned, support within AAA agencies was key and investigators spent considerable time and effort cultivating that support. Retrospectively, it may have been helpful to spend even more time working with all levels of agency personnel before initiating the intervention, but it is highly unlikely that staff or administration would have been amenable to the additional time that would require. We did work individually and in groups with agency administrators and staff, communicating regularly via email, telephone, and by attending statewide administrative meetings throughout the project. Face-to-face meetings with the administrators were most effective, but these were more difficult with the most distant AAAs. Second, although caregiver/PWD gains were maintained at follow-up, it is unlikely these gains will be maintained without ongoing support. Although agencies were committed to conducting RDAD-NW, it is clear they cannot sustain it without additional funding. How to secure those funds is beyond the purview of this study but sustained funding is essential if translational efforts are to remain grounded in the community.

There were also major high points in this endeavor. Agencies, staff, caregivers, and PWDs responded well to the structure and clarity of training, and to the relevance and clinical utility of its content. Letters of appreciation from caregivers were not unusual; caregivers often spontaneously reported that they were coping better and problems were being alleviated. RDAD-NW now has more evidence to support its effectiveness. Our program resources for PWD, families, and caregivers have been well developed and tested. These resources are now readily available in their current paper and DVD format, and we anticipate seamless migration of these materials into other media and platforms. Dissemination of these materials will provide ongoing methods to help caregivers learn the necessary skills to increase their ability to handle difficulties and improve the lives of those for whom they care and for themselves.

Conclusion

Results of this effectiveness trial indicate that community health providers in a wide range of community settings can deliver RDAD-NW with a high degree of fidelity. Both PWDs and caregivers significantly increased their physical activity levels during the 4-month treatment period. Although activity levels gradually decreased over time, levels remained significantly higher at 13 months, despite progression of cognitive impairment. In addition to the physical activity outcomes, each member of the dyad experienced other benefits during the active treatment period, including improved quality of life for PWDs and decreased depressive symptoms for caregivers. This investigation provides important evidence of the effectiveness of RDAD-NW as a community-based approach to improving health and quality of life for individuals with dementia and their caregivers, and supports the benefit of addressing both physical and psychosocial aspects of the disease process. It also highlights the potential for AAA case managers to lead the way in improving care in the community. This potential cannot be realized, however, until we can provide adequate financial resources to these agencies. Staff must be trained, supervised, and maintained. Until revenue streams for these activities are solidified and dementia care is prioritized, translational efforts such as successfully completed here, will, of necessity, be limited.

Funding

This work was supported by the National Institute on Aging (grant number R01 AG 041716 and 5 P30 AG034592 to L.T).

Conflict of Interest

None reported.