Creating harmony at home via environmental cueing: A feasibility trial of a non‐pharmacological intervention for rural caregivers of persons with dementia

Abstract

INTRODUCTION

Behavioral and psychiatric symptoms of dementia (BPSDs) and functional impairment have a major impact on quality of life for people living with dementia (PLWD). Development of caregiver‐initiated interventions, including environmental assessment and modification, are priorities in the field.

METHODS

An open‐label study of 40 caregivers of PLWD with BPSDs that underwent a 6‐week telehealth person‐environment intervention, Harmony at HOME, was conducted. Feasibility was assessed by improved caregiver mastery.

RESULTS

Twenty‐eight caregivers completed the intervention, which increased caregiver mastery and decreased stress and burden. There were statistically significant improvements in functional performance of the person living with dementia (p < 0.005) and caregivers’ satisfaction with the person living with dementia's functional performance (p < 0.001).

DISCUSSION

The intervention increased caregivers’ skills and knowledge in assessing and modifying the environment to address BPSDs. Although overall caregiver mastery was not changed significantly, additional clinical research assessing caregiver mastery in relation to specific caregiving tasks within the home environment is needed.

CLINICAL TRIAL REGISTRATION

Clinicaltrials.gov NCT05202223

Highlights

• Aging in place is difficult to achieve for individuals with dementia.

• A novel dyadic care intervention, Harmony at HOME, improved caregiver outcomes.

• Future care research should explore performance‐based patient outcomes.

1. BACKGROUND

Most older adults want to age in their homes. This is challenging for people living with dementia (PLWD), ¹ as progressive functional impairment requires supports for self‐care and management of behavioral and psychiatric symptoms of dementia (BPSDs). Common BPSDs include apathy, depression, agitation, and sleep disorders. ² , ³ , ⁴ , ⁵ Functional impairment and BPSDs contribute to increased caregiver burden, institutionalization of the person living with dementia, decreased quality of life, and PLWD mortality. ⁶ , ⁷ , ⁸ , ⁹ , ¹⁰ The U.S. Department of Agriculture reports 85% of “older age counties,” that is, counties with at least 20% of their population 65 years of age or older, are rural. ¹¹ Residence in rural communities complicates care for PLWD due to limited access to health care, caregiver training, and in‐home caregiver support, placing additional burden on family caregivers. ¹² , ¹³ , ¹⁴ Recently, the Agency for Healthcare Research and Quality ⁷ revealed that dementia care interventions implemented by caregivers have weak evidence, and in some areas, evidence is non‐existent for underrepresented groups, such as those in rural communities. ¹⁴ , ¹⁵ Well‐designed approaches to increase caregiver skills and knowledge to care for PLWD in rural communities are greatly needed to support the aging demographic.

Functional impairment and BPSDs can impact every activity required to live at home and are highly influenced by contextual factors of the situation. ¹⁶ For example, personal factors, such as functional abilities and personal preferences, influence how PLWD interact with their physical environment, such as stairs or bathroom design. ¹⁷ The interaction between personal factors and environmental affordances, described as “person–environment fit” (PE‐fit), ¹⁸ is central to the intervention described in this article and is guided by Lawton and Nahemow's Environmental Press Theory. ¹⁹ , ²⁰ When PLWD become unable to adapt to situational circumstances independently, these individuals rely on caregivers to adapt/create a supportive environment. With proper training and confidence in their skills, caregivers can assess and promote PE‐fit, which can mitigate BPSDs and functional impairment. ⁷ This article explores the role that mastery has in achieving PE‐fit.

Mastery has long been explored in dementia caregiving as a means to measure and decrease the stress and burden associated with caring for PLWD. ²¹ , ²² Caregiver mastery is thought to produce successful exchange between the person living with dementia and their caregivers. Currently, there are interventions aimed at increasing caregiver mastery, such as the Savvy Caregiver Program, ²³ and interventions to intervene in the home environment, ²⁴ but there are limited interventions designed for caregiver training to promote a level of mastery in the often changing person–environment interaction, and none that are designed specifically for implementation in a rural community setting. Integration of practical approaches from both social work and occupational therapy promotes strategies to support achieving caregiver mastery in the home environment. ²⁵ , ²⁶ , ²⁷

RESEARCH IN CONTEXT

1. Systematic review: Dementia care interventions implemented by caregivers for those living at home have weak evidence, and in some areas, evidence is non‐existent for underrepresented groups, such as those in rural communities. Well‐designed approaches to increase caregiver skills and knowledge to manage the behavioral and psychiatric symptoms of dementia in the home within rural communities are greatly needed to support the aging demographic.

2. Interpretation: Harmony at HOME aimed to improve care partner skill and capacity related to specific tasks. Success of the dyadic care intervention was observed through numerical improvements in caregiver mastery, burden, and stress, as well as significant improvement in functional performance of the person living with dementia.

3. Future directions: Future dyadic care interventions of similar mechanisms used in Harmony at HOME (i.e., person–environment fit) may benefit from using performance‐based primary outcomes that could be most appropriate for this type of intervention.

Harmony at HOME (Help Online Modifying the Environment) is an innovative intervention that promotes PE‐fit by providing knowledge and skills for dementia caregivers related to environmental modification techniques. ²⁸ Environmental modification employs environmental cueing ²⁹ and consideration of sensory processing of PLWD ³⁰ to encourage adaptive behavior within the home. With the skills acquired using Harmony at HOME, caregivers learn to moderate the functional activity engagement and BPSD of PLWD. The intervention protocol and feasibility have been demonstrated with substantial improvements in PLWD functional performance (p = 0.036) and caregiver satisfaction (p = 0.006). ²⁸ Although the intervention has been assessed in urban settings, ²⁸ feasibility is unknown when applied in rural settings. Rural caregiving for PLWD has cultural and practical differences. For example, health knowledge related to Alzheimer's disease and related dementias (ADRD) can be lower in rural residents. ¹⁵ Fewer care supports as well as lower utilization of available supports have been reported in rural caregivers, as well. ³¹ , ³² Due to differences in experiences of rural caregiving for ADRD, investigation is needed to assess feasibility related to rural application and implications for caregiver mastery when delivering Harmony at HOME and is the emphasis of this study. We seek to understand how mastery relates to the experiences of caregivers in managing everyday activities of the person living with dementia who has changing daily needs.

2. METHODS

This study utilized a single‐arm, non‐randomized clinical trial design following the National Institutes of Health (NIH) Stage Model ³³ for behavioral intervention development (clinicaltrials.gov NCT05202223). All methods were approved by the University of Kentucky Institutional Review Board.

2.1. Participants

Participants included primary caregivers and the person living with dementia they cared for, with each pair creating a dyad. All caregiver–participant pairs were consented. Legally authorized representatives, when appropriate, obtained assent from participants with cognitive impairment and provided written consent for participation. The dyad approach was critical in this study, as both individuals were involved in individualization of the intervention and training. Participants resided in the home environment in rural communities, including Appalachia. Participants were recruited through partnerships with local health care centers, community support groups, and the University of Kentucky Alzheimer's Disease Research Center. There were no exclusions for race, gender, or ethnic category. PLWD had diagnoses of ADRD confirmed by the Clinical Dementia Rating (CDR) scale and clinical assessment. Inclusion and exclusion criteria are listed in Table 1.

TABLE 1.

Inclusion and exclusion criteria.

Care partner	Person living with dementia
Inclusion
Men or women 21–99 years of age, inclusive Willingness and ability to participate in trial and implement recommended intervention strategies throughout duration of study Access to and ability to use video technology (Zoom) for telehealth visits English speaking, able to read and write Ability to retrieve and return mail Care provider of person with diagnosis of dementia with behavioral disturbance	Men or women 65–99 years of age, inclusive Diagnosis of Alzheimer's disease as a primary dementia type of moderate to severe stages (confirmed by Clinical Dementia Rating scale score of 1.0+) with behavioral disturbance Living at home in the community with one primary caregiver No change in medical condition for 1 month prior to screening visit No change in medications for 4 weeks prior to screening visit If taking psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study Physically acceptable for this study as confirmed by medical history, physical exam, and/or clinical tests completed by medical professional (MD, APRN, PA, RN, or OT) Functional sensory abilities with or without aids (hearing, vision, smell, touch, and taste) Contact with medical provider or patient's primary care physician within 12 months of study recruitment
Exclusion
Unable to provide consent for participation due to cognitive impairment Severe psychological stress or active state of psychiatric conditions (severe depression, mania, hallucinations/delusions)	Unstable medical conditions within 1 month prior to screening visit, such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems Initiation of antipsychotic medication within 4 weeks prior to screening or unpredictable use of such medications Residence in a skilled nursing facility or facility‐based care Skin lesions or skin abnormalities throughout the upper extremities Allergies related to lotion or fragrance Caregiver report of physically violent behaviors Wheelchair or bed‐bound Diagnosis of profound or total sensory altering disorders, including macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, Anosmia Major depression in past 12 months (DSM‐IV criteria), major mental illness such as schizophrenia, bipolar disorder, personality disorders, or recent (in past 12 months) alcohol or substance abuse Diagnosis or concern of epilepsy Use of any investigational agents or devices within 30 days prior to screening Major infection within 4 weeks prior to the Baseline Visit

2.2. Outcomes

The primary outcome of this study was feasibility of Harmony at HOME to change caregiver mastery measured using the Pearlin Mastery sub‐scale (a = 0.74). ²² , ³⁴ Scores of the four‐item subscale range from 4 to 16, with higher scores indicating greater levels of mastery. Secondary outcomes examined change in caregiver burden measured via the Zarit Burden Interview ³⁵ , ³⁶ (a = 0.78; a 22‐item questionnaire with a maximum score of 88, and higher score indicating higher burden experienced), caregiver perceived stress measured via the Perceived Stress Scale ³⁷ (a = 0.84–0.86; data collected via survey with the maximum total score possible as 40; higher values represent a higher perceived stress), caregiver appraisal measured via the Caregiver Appraisal Scale ³⁸ (a = 0.67–0.76; data collected via a 5‐point Likert scale with higher scores indicative of greater overall satisfaction), and change in BPSD measured via the 24‐item Revised Memory and Behavior Problems Checklist ³⁹ , ⁴⁰ (RMBPC; a = 0.67–0.90; data collected via 5‐point Likert scale with higher scores indicating greater behavioral problems). Exploratory outcomes included change in functional performance and caregiver satisfaction of the person living with dementia's functional performance as measured by the Canadian Occupational Performance Measure (COPM). ⁴¹ , ⁴² COPM is a validated and reliable goal attainment assessment used within occupational therapy goal selection and is conducted through interviews with the person living with dementia (when appropriate) and caregivers in which participants discuss capacity for daily activity completion, areas of concern, and rank all areas in terms of importance for their situation. In this study, participants co‐identify, with the interventionist, the two most important activities in goal selection. These two activities are ranked on a Likert scale of 1–10, with 1 representing the least and 10 as most in regard to PLWD functional performance and caregiver satisfaction of that level of PLWD performance on the specific activity.

2.3. Intervention

Harmony at HOME was implemented through established protocolized scripts used by interventionists and a printed curriculum “workbook” guide for participants. The protocol incorporates four guiding principles: (1) care partner capacity in using the antecedent, behavior, consequence model ⁴³ , ⁴⁴ ; (2) person‐centered approach ⁴⁵ , ⁴⁶ ; (3) environmental cueing ⁴⁷ ; and (4) guided discovery ⁴⁸ for goal selection. Examples from the intervention include decluttering the living space, reducing background noise, increasing natural light, accommodations for visual accessibility to commode, and the use of caregivers as an environmental cue in emotional contagion. These mechanisms intervene in areas of behavioral regulation, ⁴⁹ specifically during functional activity participation, ⁵⁰ , ⁵¹ and caregiver satisfaction of the person living with dementia's functional performance. ⁵²

Pre‐determined decision matrices were used to individualize the intervention plan based on participant‐specific results of the following assessments: RMBPC, ³⁹ the Adult Sensory Profile, ⁵³ COPM, ⁴² and the Home Occupation Environment Assessment. ⁵⁴ Determining specific needs and capacities of the dyad based on the above assessments guides the intervention to address needs‐driven care, implement sensory stimulation as an environmental cue to promote functional activity performance, and improve behavioral regulation. All intervention components were based on the initial protocol without adaptation and delivered through a telehealth platform as remote delivery was established and used in prior studies. A single interventionist was used for all participants to minimize risk of bias. The interventionist was licensed and registered as an occupational therapist and completed 10 contact hours of training in protocol delivery. Bi‐weekly communications were maintained with the study principal investigator to answer any questions, review participant progress, and ensure fidelity of intervention delivery. Furthermore, all treatment sessions were audio and video recorded and randomly assessed for fidelity and protocol adherence throughout the duration of the study. Primary caregivers convened with the interventionist one time per week for 45–60 min per session over 6 weeks on Zoom video conferencing.

2.4. Analysis

Participant characteristics and demographics were assessed using descriptive statistics. For purposes of analysis, individuals were divided into two groups based on cognitive impairment as reported by caregivers: mild/moderate and severe. Using a linear mixed model, analyses compared means among three data points (baseline, post‐intervention, 4‐week follow‐up). Intent‐to‐treat (ITT) analyses were completed, as well as a modified ITT of participants who completed the post‐intervention data point. In addition, participants were stratified based on cognitive impairment severity based on cognitive and functional assessment: mild/moderate (MM) and severe (S). Analyses were conducted using PC‐SAS9.4. Statistical significance was determined at the 0.05 level throughout.

3. RESULTS

Forty caregiver/person living with dementia dyads were consented into this study. Thirty‐four dyads initiated Harmony at HOME, but eight did not complete the full 6 weeks of planned intervention (76% were retained). Of the 26 caregivers who completed the study, the majority were White, female caregivers with a mean age of 62.6 years. Demographic information is provided in Table 2.

TABLE 2.

Participant characteristics.

Participant characteristics	Caregiver	Person with dementia
Total N	26	26
Mild/moderate cognitive Impairment (n)	18	18
Severe cognitive impairment (n)	8	8
Age (years; mean ± SD)	62.6 ± 2.1	80 ± 1.3
Gender (f/m)	22/4	19/7
Race (w/b)	25/1	25/1
Education (years; mean ± SD)	17.4 ± 0.2	n/a
Length of caregiving relationship (years; mean ± SD)	5.8 ± 1.6	n/a

Abbreviations: B, Black/African American; F, female; M, male; N, Number; N/A, not applicable; SD, standard deviation; W, White.

Of the six dyads who did not start the intervention phase, the reasons included: person living with dementia died (n = 1), person living with dementia transitioned to higher levels of care out of home (n = 2), time constraints (n = 1), and no show/loss of contact (n = 2). Reasons for lack of intervention completion were noted as caregiver illness (n = 2), time constraints (n = 2), person living with dementia death (n = 1), no show/loss of contact (n = 1), technology hesitation (n = 1), and natural disaster/flooding (n = 1). There were no significant differences between those who completed the study and those who did not, except for the length of caregiving for the person living with dementia. Those who completed the study provided care for an average of 1.7 years longer than those who did not complete the study (x̄ = 3.8 years for completers compared to x̄ = 2.1 years for non‐completers; p = 0.01).

The primary outcome of caregiver mastery demonstrated numerical increases from baseline to post‐intervention; however, these increases were not statistically significant. Caregiver appraisal also demonstrated numerical increases but these were not statistically significant. This was also the case for areas where the intervention aimed to decrease caregiver burden, with greater reduction observed in caregivers of persons with greater severity and BPSD. Perceived stress did not change for caregivers of individuals with mild to moderate dementia and demonstrated numerical improvements for caregivers of persons with severe dementia. Exploratory outcomes of functional performance of PLWD and caregiver satisfaction related to the functional performance of PLWD demonstrated statistically significant improvement from baseline to post‐intervention. Outcome data of the measures are reported in Table 3.

TABLE 3.

Mean and standard deviation of each outcome at baseline, post‐intervention, and 4 ‐week follow‐up by patient severity level.

Outcome	Cognitive impairment Group	Baseline Mean (SD)	Post‐intervention Mean (SD)	4‐Week follow‐up Mean (SD)
Pearlin Caregiver Mastery	MM	12.3 (2.1)	12.8 (1.5)	13.0 (1.5)
	Sev	13.3 (2.1)	13.5 (1.8)	13.0 (2.0)
Zarit Caregiver Burden	MM	30.7 (12.1)	29.9 (12.9)	31.1 (13.3)
	Sev	36.0 (14.7)	31.1 (9.3)	32.5 (11.9)
Perceived Stress Scale	MM	31.1 (3.7)	31.9 (3.5)	30.7 (2.3)
	Sev	33.4 (2.6)	32.8 (3.5)	32.1(3.5)
Caregiver Appraisal Scale	MM	22.1 (1.7)	22.2 (1.3)	21.7 (1.8)
	Sev	21.5 (2.1)	21.9 (2.2)	20.8 (1.0)
Revised Memory and Behavior Problems Checklist (Frequency)	MM	33.3 (14.2)	32.8 (12.2)	33.1 (13.3)
	Sev	27.3 (18.6)	26.6 (17.4)	28.9 (18.0)
Revised Memory and Behavior Problems Checklist (Reaction)	MM	16.7 (12.9)	15.1 (9.6)	16.5 (12.8)
	Sev	14.1 (19.6)	12.8 (13.1)	13.1 (12.5)
Canadian Occupational Peformance Measure: Functional Performance	MM	5.5 (2.5)	6.6* (1.7)	N/A
	Sev	3.1 (1.2)	5.6* (2.3)	N/A
Canadian Occupational Performance Measure: Caregiver Satisfaction	MM	5.3 (2.1)	7.3** (1.7)	N/A
	Sev	4.0 (2.0)	6.6**(1.8)	N/A

Note: Denotes significant increases at p < 0.05 (*) or p < 0.01 (**).

Abbreviations: MM, mild/moderate; SD, standard deviation; Sev, Severe.

4. DISCUSSION

This single‐arm clinical trial assessed the feasibility of the Harmony at HOME intervention to improve caregiver mastery among care partners of rural, community residing PLWD. Although the study's primary outcome did not reach statistical significance, all outcomes trended in desirable directions, demonstrating feasibility of this intervention to increase caregivers’ skills and knowledge in management of functional performance and BPSD. Exploratory outcomes related to functional activity performance of PLWD demonstrated statistical significance following the 6‐week intervention.

Use of caregiver mastery is a commonly used outcome in dementia caregiving research. ⁵⁵ , ⁵⁶ , ⁵⁷ By definition, caregiver mastery is oriented around how one perceives their life chances under their personal control as described above. ²¹ Use of mastery as an outcome in clinical interventional studies focused on performance of PLWD may present challenges because of the fluctuation in functional performance of PLWD based on the complexity of the task, time of day, BPSD presentation, and availability of environmental supports. In addition, there are varied responses from PLWD regarding the care provided (i.e., facilitated care vs verbal direction can create different responses in PLWD during a care task). These factors, by nature, may be beyond the perceptions of control by the caregiver as described in the definition of mastery. Furthermore, perception of caregiver mastery is highly subjective and may reflect other psychosocial processes of the care situation outside of the controlled clinical trial. Measurement of caregiver mastery is also challenging because mastery is experienced when situations are under one's control and the person feels they have a high level of knowledge and skills. ⁵⁸ When using this type of outcome in clinical trials, it may be most beneficial to assess knowledge, skills, and competency. ⁵⁹ Mastery of providing care may be obtainable in static health conditions but may only be obtainable during specific phases of dynamically progressive neurodegenerative conditions. The continual decline in capacity and performance of PLWD creates a moving target, so‐to‐speak, as one day caregiver mastery may be perceived, but the next day the caregiver may face new challenges and deficits. For example, some studies have suggested caregiver mastery may be lower when PLWD have a higher severity of BPSD. ⁶⁰ Findings indicate that a performance‐based primary outcome may be most appropriate for this type of intervention.

Several secondary outcomes were included to assess care partner well‐being (burden, stress, and appraisal). The intervention delivered over 6 weeks via telehealth demonstrated numerical improvements in these areas. It is important to note that many caregivers of PLWD during these stages experience substantial burden and stress. Adding a non‐pharmacological interventional clinical trial to their care routine had the potential to increase these domains; however, that was not the case with Harmony at HOME. The added tasks of the intervention did not worsen feelings of burden or stress, and although not statistically significant, these areas saw improvement or stability over time. Several factors may have influenced the lack of statistical significance of these findings. The intervention contact time may have been too low, as other 6‐week caregiver interventions assessed in clinical trials provided up to 45 min of additional contact time during weekly visits. ⁶¹ In addition, tailoring the intervention to the needs of rural caregivers observed in the literature, ¹⁵ such as increased education related to ADRD and explanation of the available community supports, may have increased the impact on these outcomes.

This study was successful in laying the groundwork for Harmony at HOME as a primary mechanism for tailoring of the care training based on the situation ¹⁶ and to specific behavioral disturbances during daily activity performance, such as bathing or feeding. The intervention protocol is sustainable within the current health care landscape when delivered by occupational therapists, as this is reimbursable by insurance, including Medicare and Medicaid, and expands intervention options into areas known for being medically underserved. ³¹ This study builds on evidence strengthened during the coronavirus disease 2019 (COVID‐19) pandemic, which illustrates success in behavioral interventions in rural communities with telehealth implementation. ⁶² Furthermore, a large systematic review of dementia care interventions conducted by the Agency for Health Quality Research supports the use of telehealth in dementia caregiver interventions. ⁷ Combining these successful elements with the literature illustrating reduced care partner burden and stress when given skills for care provision, ⁶³ Harmony at HOME provides an opportunity for substantial public health impacts to support aging in place despite living with cognitive impairment in rural communities.

This study has several limitations that should be considered when interpreting the findings. First, the sample in the current study was not diverse in terms of ethnicity and race. Although the study is representative of geographic diversity, there was limited enrollment of individuals who were racially and/or ethnically diverse. Based on United States Census data, the recruitment regions of individuals age 65 years and older have limited racial/ethnic diversity such as 5.5% Black/African Americans, 1% Hispanic, and 2.6% more than one race. ⁶⁴ Of the total enrolled participants (caregivers and PLWD), this study included 2.5% racially diverse participants. Future studies should consider diverse and more sophisticated sampling methods including oversampling of minority populations (e.g., Black, Hispanic) to create a sample that is larger and more representative of the overall population of rural areas. Future, larger clinical trials will allow opportunity to explore implications of characteristics such as length of caregiving roles, socioeconomic factors, and racial/ethnic differences, as well as broad implementation factors. In addition, future studies may explore barriers to engagement for caregiver–person living with dementia dyads from underrepresented backgrounds in participating in interventions like Harmony at HOME. A sample size of 40 dyads was planned; however, 26 dyads were included in the analyses due to participant drop out. This information is useful for future power calculations considering the nature of severity in the degenerative processes. Furthermore, because this was a pilot investigation, no control over the possible inflation of the type I error rate due to examining multiple endpoints was conducted.

Although the Harmony at HOME intervention expands caregivers’ abilities to use environmental modifications in caring for the person living with dementia at home, additional adaptation may be needed to enhance caregiver confidence and self‐efficacy in relation to providing care in a degenerative condition. We did not find that caregiver mastery as defined by Pearlin was useful in capturing the improvements in providing care to support the daily function of PLWD. Future iterations of research will attempt to capture caregiver confidence and self‐efficacy.

Overall, caregivers were enthusiastic about Harmony at HOME and experienced increased satisfaction and observed improvements in functional performance for the person living with dementia. The study demonstrated the feasibility to increase skills and knowledge in managing BPSD, but caregivers did not yet reach mastery. Factors such as sample size, program duration, and emphasis in adaptation of interventions to rural communities may strengthen future evidence of non‐pharmacological interventions.

CONFLICT OF INTEREST STATEMENT

The authors have no conflicts of interest to report. Author disclosures are available in the Supporting Information.

CONSENT STATEMENT

All human subjects provided written informed consent as approved by the University of Kentucky Institutional Review Board.

Supporting information

Supporting Information

Rhodus EK, Kryscio R, Jicha G, et al. Creating harmony at home via environmental cueing: A feasibility trial of a non‐pharmacological intervention for rural caregivers of persons with dementia. Alzheimer's Dement. 2025;21:e70405. 10.1002/alz.70405