Abstract
Context
People with chronic obstructive pulmonary disease (COPD) experience dyspnea with activities despite optimal medical management.
Objectives
The purpose of this study was to test the efficacy of two 12-month dyspnea self-management programs, Internet-based (eDSMP) and face-to-face (fDSMP), compared with a general health education (GHE) control on the primary outcome of dyspnea with activities.
Methods
Participants with COPD were randomized to eDSMP (n=43), fDSMP (n=41) or GHE (n=41). The content of the DSMPs were similar and focused on education, skills training, and coaching on dyspnea self-management strategies, including exercise, and only differed in the delivery mode. Dyspnea with activities was measured with the Chronic Respiratory Questionnaire at three, six, and 12 months. Secondary outcomes included exercise behavior and performance, health-related quality of life (HRQL), self-efficacy for dyspnea management, and perception of support for exercise. The study was registered at Clinicaltrials.gov (NCT00461162).
Results
There were no differences in dyspnea with activities across groups over 12 months (P=0.48). With the exception of arm endurance (P=0.04), exercise behavior, performance, and HRQL did not differ across groups (P>0.05). Self-efficacy for managing dyspnea improved for the DSMPs compared with GHE (P=0.06). DSMP participants perceived high levels of support for initiating and maintaining an exercise program.
Conclusion
The DSMPs did not significantly reduce dyspnea with activities compared to attention control. However, the high participant satisfaction with the DSMPs combined with positive changes in other outcomes, including self-efficacy for managing dyspnea and exercise behavior, highlight the need for additional testing of individually tailored, technology-enabled interventions to optimize patient engagement and improve clinically relevant outcomes.
Keywords: Self-management, self-care, dyspnea, pulmonary disease, COPD, chronic disease, health behavior, health education, internet, smartphone, cell phone
Introduction
Dyspnea is a distressing symptom that contributes to significant disability and poor quality of life in patients with chronic obstructive pulmonary disease (COPD).1 Despite optimal medical therapy and rehabilitation, nearly 75% of individuals with COPD continue to experience dyspnea with daily activities, and at rest near the end of life.2, 3 Pulmonary rehabilitation (PR) is a guideline-recommended therapy for COPD and a covered benefit for Medicare beneficiaries. However, a number of logistical barriers exist to participation.4 Moreover, PR follows an episodic care model that does not parallel an illness trajectory that may span 25 years.5 Most people with chronic diseases and their caregivers still desire and require ongoing convenient and easy access to resources for education, skills training, and support for self-management.
The development of innovative approaches to provide these resources continues to be of utmost importance. Interventions that support self-management are generally designed to provide patients with the essential knowledge and skills to effectively cope with the demands of their illness while maintaining an acceptable level of social and physical functioning and quality of life.6–9 The pervasive use of information and communication technologies (ICT) in everyday life provides a natural channel to foster resources for patient self-management. Recent studies of ICT-enabled care have shown positive outcomes for COPD10–13 and other clinical populations.14–17 We previously found that two versions of a dyspnea self-management program (DSMP), one conducted using traditional mediums, e.g., face-to-face and telephone,18, 19 and an ICT-enabled version,20, 21 reduced dyspnea with activities in patients with COPD. However, the previous studies did not include an attention control group and our evaluation of the Internet-based DSMP had several methodological limitations.21
Therefore, the purpose of this study was to test the efficacy of two 12-month DSMPs, Internet-based (eDSMP) and face-to-face (fDSMP), compared with a general health education (GHE) attention control intervention on the primary outcome of dyspnea with activities in individuals with COPD. We hypothesized that the two DSMPs would result in clinically important reductions in dyspnea with activities compared with the attention control.
Methods
Study Design
We conducted a randomized, repeated measures (0, 3, 6, 12 months) study to test the efficacy of two 12-month DSMPs, eDSMP and fDSMP, compared with GHE. The trial was approved by the respective institutional review boards at two academic medical centers, the University of California, San Francisco (10-02992, San Francisco General Hospital Panel) and the University of Washington, Seattle (30080, Committee B) and was registered with ClinicalTrials.gov (NCT00461162).
Participants
Participants were recruited from a combination of online and off-line sources. The inclusion criteria were:1) a diagnosis of COPD and clinically stable for at least one month; 2) forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio <0.70 with FEV1<80% predicted or FEV1/FVC <0.60 with FEV1>80% predicted or CT confirmed emphysema; 3) activities limited by dyspnea; 4) use of the Internet; and 5) oxygen saturation >85% on room air on ≤6L/min of oxygen at the end of a six-minute walk test (6MWT). Participants were excluded if they: 1) had active symptomatic illness (e.g., cancer, heart failure); 2) participated in PR in the last six months; or 3) were currently participating in more than two days a week of supervised exercise.
Procedures
Baseline assessments included spirometry, completion of web questionnaires, and exercise performance tests. Spirometry was performed using a KoKo® spirometer (Pulmonary Data Services, Louisville, CO). All participants received a home visit by either an advanced practice nurse (eDSMP and fDSMP) or a graduate research assistant. Participants returned to the medical center at three, six, and 12 months for testing by study staff who were not involved in the intervention.
Dyspnea Self-Management Programs (fDSMP and eDSMP)
Major concepts from social cognitive,22, 23 self-management,24 and pathophysiological25 theories as well as our previous work on dyspnea self-management18, 19, 21, 26 provided the framework for these self-efficacy enhancing programs. The DSMPs included: individualized education and demonstration of dyspnea self-management strategies, including an action plan for exacerbations, a tailored exercise and activity plan with biweekly personalized reinforcement and feedback, and self-monitoring of symptoms and exercise. Both programs provided similar content and “contact” time and differed only in the mode of delivery (Table 1). The eDSMP incorporated technological enhancements to support earlier recognition of worsening symptoms through real-time monitoring, prompt feedback, and convenient access to information and support.
Table 1.
Core DSMP Components
| Core Components | eDSMP | fDSMP |
|---|---|---|
| 1. Dyspnea and exercise consultation (1–1.5 hours) | Individual face-to-face + Training on website & smartphone | Individual face-to-face |
| 2. Endurance (4×/week, 30 minutes per session) and arm strengthening exercise (3×/week) program | Unsupervised independent exercise | Unsupervised independent exercise |
| 3. Collaborative self-monitoring of exercise and respiratory symptoms & reinforcement of dyspnea management strategies (weekly in month 1; biweekly months 2–12) | Smartphone and web diary Reinforcement emails | Paper diaries Reinforcement telephone calls (5–10 mins) |
| 4. Structured education, skills training and peer interactions (six 1-hour sessions) | Interactive web modules Live group chat sessions & access to chat transcripts Bulletin boards | Paper modules Face-to-face group sessions |
Details of the four major components of the DSMPs are described below.
Dyspnea and Exercise Consultation
An advanced practice nurse who specialized in either general adult or pulmonary medicine visited participants in their homes within one week of their baseline visits to conduct a 1.5–2 hour face-to-face dyspnea assessment and consultation. The goal of the consultation was for the nurse to establish rapport with the participant and to understand his or her current level of exercise and experiences with dyspnea through motivational interviewing techniques.27 An individualized exercise plan was developed with the participants, and actions that they could take to prevent and manage future COPD exacerbations were discussed. The eDSMP participants were provided a detailed paper “Help Manual” and training on how to navigate and use the website tools and study-issued smartphone, Palm Treo 650/680/700®.
Exercise Program
During the consultation visit described above, the nurse and participant together developed an individualized exercise plan that was based on the participant’s baseline exercise performance, dyspnea with exercise testing, oxygen saturation, stage of exercise motivational readiness and exercise preferences. The home-based exercise program included a combination of endurance (e.g., walking, cycling, or swimming) and arm strengthening (bicep curls, triceps curls, side arm raises, and upper arm raises) exercises. Participants were encouraged to complete endurance exercises at least four times per week for 30 minutes per session and arm strengthening exercises at least three times per week. They used a modified 0–10 point Borg scale28 to gauge their dyspnea as a proxy for exercise intensity and were instructed that they should feel at the end of their exercise that they could have not gone further. Participants who were more disabled were encouraged to perform their endurance exercises in smaller 10-minute increments.
Collaborative Self-Monitoring and Reinforcement
eDSMP participants submitted real-time information about their symptoms (dyspnea, cough, and sputum) and exercise (mode, duration, and worst dyspnea) using their desktop computer or smartphone; if they reported not exercising, they were asked to select from a list of reasons that kept them from exercising that particular day. fDSMP participants completed paper diaries and mailed them back weekly to the study office. eDSMP participants were encouraged to communicate their exercise goals and progress to the nurse by using a web-based goal setting tool on their desktop, whereas the fDSMP group set exercise goals during the telephone calls and on their paper logs. The nurses used this information to provide individualized feedback and reinforcement to participants regarding their use of dyspnea management strategies and exercise progress via email (eDSMP) or telephone (fDSMP) weekly for the first month and then biweekly for 11 months. These contacts were designed to be as similar as possible for the two groups. One difference was that automated real-time email alerts were sent to the nurses if eDSMP participants reported worsening of symptoms. There were no alerts for the fDSMP participants.
Structured Education Sessions and Peer Interactions
All participants received education on shortness of breath (SOB), breathing strategies to reduce SOB, exercise and SOB, modifying activities to reduce SOB, coping with SOB and stress, and medications to manage SOB and COPD flare-ups. The eDSMP group accessed web-based education modules, whereas the fDSMP participants were given a paper copy of the modules on these six topics. The web-based flash modules, which were written at the eighth-grade level or lower, also had non-digitized audio, pictures, and animations. The content from these modules was reinforced by the nurses during six, monthly, live chat sessions with participants from both clinical sites (eDSMP) or face-to-face meetings at the respective medical centers (fDSMP). These education sessions were designed to encourage peer interactions and mutual support.
General Health Education Attention Control
GHE participants received a home visit from one of the study staff, participated in monthly face-to-face education classes that focused on health topics of interest to middle- and older-aged adults and unrelated to lung disease (e.g., nutrition, general safety with medications). Participants were mailed the educational materials if they did not attend the sessions. Participants also received biweekly phone calls that provided general health information. GHE participants were offered the opportunity to participate in the DSMPs at the end of the control period.
Measures
Primary Outcome
Dyspnea with activities was measured with the Chronic Respiratory Questionnaire dyspnea (CRQ-D) subscale.29, 30 Higher scores indicate less dyspnea. The benchmark for a minimal clinically important difference (MCID) in mean scores is 2.5.31
Secondary Outcomes
Exercise performance was measured with a 6MWT32 and a symptom-limited incremental treadmill test (ITT).33 Dyspnea was measured at the end of the 6MWT and at every stage of the ITT using the modified Borg scale. Arm endurance was assessed by having participants lift a wooden dowel (weight=165grams; length=3ft; diameter=3/4 inch) to shoulder height as many times as possible in one minute.34 Participants were asked about the frequency and duration of endurance (walking, biking, swimming) and strengthening exercises for a typical week during the last month.20, 35 The CRQ and Medical Outcomes Study Short-Form 36 (SF-36®)36 were used to measure disease-specific and general health-related quality of life (HRQL), respectively. Self-efficacy for managing dyspnea was measured with one validated question, “How confident are you that you can keep your shortness of breath from interfering with what you want to do?,” using a 0 (not at all confident) to 10 (totally confident) point scale.35 Participants also were asked two questions about their perception of support from the study nurses for initiating and maintaining an exercise program, using a seven-point Likert scale ranging from 1=strongly agree to 7=strongly disagree.37
Intervention Exposure and Satisfaction
All activities on the website were automatically logged and time stamped for eDSMP participants. Unique logins, participation in chat sessions, reinforcement follow-ups, symptom and exercise monitoring were tabulated for 12 months. Intervention contacts with the fDSMP and GHE participants were entered into a study management application. Participants were asked about their satisfaction with specific components of the eDSMP (13 items) or fDSMP (nine items) and their overall satisfaction with the programs using a four-point scale (1= very helpful to 4=not at all helpful).
Power Calculations
Our target sample size of 200 was selected to provide the study with a statistical power of 80% to detect a 2.5 point MCID between groups, with the use of a two-tailed test and adjustment for three comparisons, assuming a 20% attrition rate over 12 months (n=53 per group).
Statistical Analyses
Baseline characteristics were compared with Chi-square tests or analysis of variance. Mixed effects models adjusting for age, gender, and FEV1% predicted were used for all outcomes. An unstructured covariance matrix was used to account for covariance between repeated measures and estimation was done using maximum likelihood. We incorporated intent-to-treat principles whereby participants were analyzed according to their group assignment regardless of their adherence with the treatment and subsequent withdrawal. A “completers” analysis also was performed using repeated-measures analysis of variance. The results were similar and, therefore, only the mixed models results are reported. Additional per-protocol analyses were conducted with DSMP participants who attended four of six education/skills training sessions, had 20 of 28 follow-up contacts, had at least 365 exercise and symptom log entries, participated in three days/week of endurance exercise, and two days/week of strengthening exercises. These results were not appreciably different from the primary analyses. All analyses were performed using SPSS version 15.0 (SPSS, Inc., Chicago, IL).
Results
Patient Characteristics
A total of 711 participants were screened from March 2007 to April 2010. As shown in Fig. 1, 125 participants were randomized after 586 participants were excluded. Three participants dropped out after completing the home visit; four dropped out and one died prior to the six-month evaluation. Six additional participants dropped out and two died prior to the 12-month evaluation. Dropouts (n=16) were similar to participants who completed the study. Participants were similar at baseline across all groups (Table 2).
Figure 1.
Subject Flow
*Based on primary outcome of CRQ-Dyspnea
Table 2.
Baseline Sample characteristics (N=125)a
| Variables | eDSMP | fDSMP | GHE | Total |
|---|---|---|---|---|
| (n=43) | (n=41) | (n=41) | (n=125) | |
| Demographics | ||||
| Age, years | 68.5±11.0 | 68.2±9.9 | 69.3±8.0 | 68.7±9.7 |
| Female | 18(42%) | 22(54%) | 17(41%) | 57(46%) |
| Caucasian | 40(93%) | 37(90%) | 36(88%) | 113(90%) |
| Education | ||||
| High school or some college | 21 (49%) | 19(46%) | 23(56%) | 63(50%) |
| College or more | 20(47%) | 18(44%) | 17(42%) | 55(44%) |
| Not currently employed, disabled, retired | 34(79%) | 32(78%) | 28(68%) | 94(75%) |
| Live with spouse or other | 29(68%) | 26(63%) | 29(71%) | 84(67%) |
| Currently smoking | 2(5%) | 2(5%) | 3(7%) | 7(6%) |
| Body mass index (BMI) | 28.0±5.5 | 27.3±7.1 | 26.5±5.4 | 27.3±6.0 |
| Disease Severity | ||||
| FEV1/FVC | 0.50±0.12 | 0.47±0.11 | 0.46±0.14 | 0.48±0.13 |
| FEV1 % predicted | 53.3±20.4 | 50.6±18.2 | 49.4±19.8 | 51.1±19.5 |
| GOLD Stage | ||||
| Mild/Moderate | 22 (51%) | 19(46%) | 21(51%) | 62(49%) |
| Severe/Very Severe | 21 (49%) | 22(54%) | 20(49%) | 63(50%) |
| BODE Score | 2.3±2.1 | 3.1±2.1 | 2.6±2.1 | 2.7±2.1 |
| Supplement oxygen | 11(26%) | 10(24%) | 12(29%) | 33(26%) |
| Co-morbidities | ||||
| Cardiovascular (HTN & CAD) | 13(30%) | 9(22%) | 15(37%) | 37(30%) |
| Musculoskeletal (Arthritis & other pain) | 9(21%) | 10(24%) | 10(24%) | 29(10%) |
| Computer/Internet Use | ||||
| Comfortable with use | 39 (91%) | 36(88%) | 37(90%) | 112(90%) |
| Duration and frequency of use | ||||
| >1year | 43(100%) | 37(90%) | 39(95%) | 119(95%) |
| Daily | 33(77%) | 21(51%) | 28(68%) | 82(66%) |
| Other characteristics | ||||
| Motivational readiness for exercise | ||||
| Pre-contemplation/Contemplation | 5(11%) | 6(15%) | 10(24%) | 21(17%) |
| Preparation | 13(30%) | 14(34%) | 13(32%) | 40(32%) |
| Action | 3(7%) | 7(17%) | 4(10%) | 14(11%) |
| Maintenance | 15(35%) | 8(20%) | 9(22%) | 32(26%) |
| Relapse | 7(16%) | 6(15%) | 5(12%) | 18(14%) |
| Previous pulmonary rehabilitation | 18(42%) | 15(37%) | 14(34%) | 47(38%) |
Values are mean ± SD or (%).
HTN=hypertension; CAD=coronary artery disease.
P>0.05, no significant differences among groups and between participants and dropouts (n=16).
Primary Outcome
There were no significant differences in dyspnea with activities as measured by the CRQ-D subscale nor the number of participants who met the MCID of 2.5 points between the eDSMP, fDSMP, and GHE over 12 months (P=0.48) (Table 3). However, there were significant within-group improvements in dyspnea at 12 months in the eDSMP and at three months in the fDSMP compared with baseline.
Table 3.
Comparison of Treatment Effects: Dyspnea, Exercise Performance and Behavior, and Health-Related Quality of Life
| Time | eDSMP | fDSMP | GHE | Group | Time | Group × Time | |
|---|---|---|---|---|---|---|---|
| (n=43) | (n=41) | (n=41) | |||||
| P-values | |||||||
| Primary Outcome | |||||||
| CRQ-Dyspnea | Baseline | 23.8 (22.1, 25.5) | 22.2 (20.4, 23.9) | 23.3 (21.5, 25.0) | |||
| (5–35↑) | 3 mo | 25.4 (23.6, 27.2) | 24.1 (22.2, 26.0) a | 23.6 (21.8, 25.4) | |||
| 6 mo | 25.4 (23.5, 27.3) | 23.4 (21.4, 25.4) | 23.7 (21.7, 25.7) | ||||
| 12 mo | 26.0 (23.9, 28.1) a | 22.8 (20.6, 25.0) | 24.0 (21.8, 26.2) | .23 | .01 | .48 | |
| Secondary Outcomes | |||||||
| Exercise Performance | |||||||
| Six Minute Walk (feet) | Baseline | 1314 (1216, 1412) | 1301 (1200, 1402) | 1306 (1206, 1406) | |||
| 3 mo | 1417 (1313, 1521) b | 1381 (1273, 1489) c | 1373 (1266, 1479) c | ||||
| 6 mo | 1429 (1317, 1541) b | 1391 (1274, 1507) c | 1314 (1199, 1429) | ||||
| 12 mo | 1415 (1293, 1537) a | 1393 (1266, 1521) a | 1334 (1209, 1460) | .71 | <.001 | .21 | |
| Arm Lifts (#/min) | Baseline | 50.8 (46.2, 55.4) | 49.0 (44.2, 53.7) | 51.0 (46.3, 55.7) | |||
| 3 mo | 56.1 (50.4, 61.8) a | 52.0 (46.0, 58.0) | 52.5 (46.6, 58.3) | ||||
| 6 mo | 61.3 (55.4, 67.1) b | 57.1 (51.0, 63.1) b | 53.0 (47.1, 59.0) | ||||
| 12 mo | 62.7 (56.5, 68.9) b | 60.1 (53.6, 66.6) b | 52.7 (46.3, 59.1) | .33 | <.001 | .04 | |
| Exercise Behavior | |||||||
| Endurance Duration | Baseline | 129 (94, 164) | 106 (67, 141) | 83 (48, 119) | |||
| (mins/wk) | 3 mo | 172 (136, 208) | 148 (108, 188) | 124 (85, 162) | |||
| 6 mo | 171 (132, 210) | 126 (86, 167) | 119 (80, 159) | ||||
| 12 mo | 221(166, 276) c | 208 (150, 267) c | 115 (58, 172) | 0.04 | <.001 | .24 | |
| Endurance | Baseline | 4.2 (3.4, 5.0) | 3.9 (3.1, 4.7) | 3.7 (2.9, 4.5) | |||
| Frequency/wk | 3 mo | 5.3 (4.6, 6.0) a | 5.0 (4.2, 5.7) a | 4.5 (3.8, 5.3) | |||
| 6 mo | 5.3 (4.5, 6.1) a | 4.5 (3.7, 5.3) | 4.5 (3.7, 5.2) | ||||
| 12 mo | 5.1 (4.4, 5.9) | 4.8 (4.0, 5.6) | 4.5 (3.7, 5.3) | .26 | .001 | .97 | |
| Strengthening | Baseline | 1.3 (0.9, 1.8) | 1.1 (0.6, 1.6) | 0.5 (0.0, 1.0) | |||
| Frequency/wk | 3 mo | 2.9 (2.2, 3.6) b | 3.1 (2.4, 3.9) b | 1.3 (0.6, 2.0) | |||
| 6 mo | 3.0 (2.3, 3.6) b | 2.7 (2.0, 3.4) b | 1.0 (0.3, 1.6) | ||||
| 12 mo | 2.5 (1.8, 3.2) a | 2.6 (1.8, 3.3) c | 1.1 (0.4, 1.9) | <.001 | <.001 | .22 | |
| Health Related Quality of Life | |||||||
| CRQ-Total | Baseline | 96.4 (90.4, 102.3) | 91.5 (85.4, 97.6) | 96.2 (90.1, 102.2) | |||
| (20–140↑) | 3 mo | 102.2 (96.2, 108.2) a | 96.7 (90.4, 103.1) | 99.1 (92.9, 105.3) | |||
| 6 mo | 104.6 (98.1, 111.2) b | 96.5 (89.7, 103.3) | 97.6 (90.9, 104.4) | ||||
| 12 mo | 104.8 (97.7, 112.0) c | 96.4 (88.8, 104.0) | 98.4 (90.9, 105.8) | .28 | <.001 | .44 | |
| SF36 Physical | Baseline | 34.5 (31.8, 37.3) | 34.2 (31.4, 37.1) | 33.7 (30.9, 36.6) | |||
| Composite (0–100↑) | 3 mo | 36.5 (33.4, 39.7) | 36.1 (32.9, 39.4) | 36.1 (32.9, 39.3) | |||
| 6 mo | 37.1 (33.7, 40.4) | 36.3 (32.9, 39.8) | 35.0 (31.6, 38.5) | ||||
| 12 mo | 38.9 (35.6, 42.3)† | 35.8 (32.2, 39.3) | 35.2 (31.8, 38.7) | .68 | <.01 | .63 | |
| SF36 Mental | Baseline | 53.2 (50.1, 56.3) | 48.7 (45.6, 51.9) | 53.1 (49.9, 56.2) | |||
| Composite (0–100↑) | 3 mo | 53.7 (50.7, 56.8) | 50.9 (47.6, 54.2) | 51.1 (47.9, 54.3) | |||
| 6 mo | 52.9 (49.6, 56.2) | 59.6 (46.1, 53.0) | 51.2 (47.8, 54.6) | ||||
| 12 mo | 52.2 (48.7, 55.7) | 50.6 (46.9, 54.4) | 52.1 (48.5, 55.7) | .30 | .84 | .54 | |
| Self-Efficacy | |||||||
| Self-Efficacy for | Baseline | 4.93 (4.06, 5.80) | 4.81 (3.92, 5.71) | 5.74 (4.84, 6.63) | |||
| Managing Dyspnea (0- | 3 mo | 6.80 (5.97, 7.63) b | 5.95 (5.06, 6.84) a | 5.82 (4.95, 6.69) | |||
| 10↑) | 6 mo | 6.38 (5.45, 7.31) c | 6.25 (5.28, 7.22)† | 5.92 (4.96, 6.88) | |||
| 12 mo | 6.99 (6.07, 7.91) b | 5.94 (4.94, 6.95) | 6.35 (5.39, 7.31) | .59 | <.001 | 0.06 | |
Values are presented as mean (95% CI).
CRQ = Chronic Respiratory Questionnaire; SF-36 = Medical Outcomes Study Short Form-36; ↑ scores=better.
P<0.05;
P<0.001;
P<0.01.
Secondary Outcomes
All groups showed significant improvements in 6MWT distance over 12 months (time, P<0.001) with no differences among groups (Table 3). All DSMP participants significantly improved their 6MWT duration above baseline over 12 months; improvement in the eDSMP at six months met the MCID criterion of 35 meters.38 There were no differences among the groups on the change in performance on the treadmill test or on dyspnea intensity rated on the Borg Scale during the 6MWT and ITT (P>0.05). There was a significant group by time interaction in arm endurance (P<0.04), with DSMP participants performing more arm lifts at six and 12 months compared to GHE. All groups showed significant improvements in duration and frequency of endurance exercise and frequency of strengthening exercises over the 12 months (time, P<0.05); however, significant differences among groups on these exercise parameters were only evident in duration of weekly endurance exercise and frequency of strengthening exercise (P<0.05). Although CRQ-Total and SF-36 physical and mental composite scores were not significantly different across groups (P>0.05, all), eDSMP participants had significant improvements in CRQ-Total at all time points compared with baseline.
Differences among groups over time in self-efficacy for managing dyspnea approached significance (P=0.06), with the eDSMP group significantly improving self-efficacy at all times and the fDSMP at three and six months, compared with no changes for GHE participants. Participants in both DSMPs perceived significantly more support from the study nurses to initiate (eDSMP: 1.8 ± 1.2; fDSMP: 1.6 ± 1.1; GHE: 3.1 ± 1.9, P<0.001) and maintain (eDSMP: 1.8 ± 1.1; fDSMP: 1.6 ± 1.2; GHE: 3.3 ± 1.9, P<0.001) their exercise programs compared with GHE participants.
Intervention Exposure and Satisfaction
eDSMP participants logged into the website a mean±SD of 178 ± 133 (median, 148) over the 12 months. Approximately 75% of the eDSMP participants used the website or smartphone at least once through the 12 months. There were significant differences across groups in the number of education sessions attended (eDSMP: 3.1±2.2, fDSMP: 4.4±2.1, GHE: 2.2±2.1, P<.001) and successful follow-up contacts (eDSMP: 24.1±6.1, fDSMP: 21.8±7.3, GHE: 19.2±6.8, P=0.004). There were no differences between the DSMPs in these two variables, but the fDSMP attended more education sessions and the eDSMP had more follow-up contacts compared to the GHE (both, P<0.01). There were no differences in the number of logged entries for exercise (eDSMP: 195±135 vs. fDSMP: 210±139) or symptoms (eDSMP: 184±147 vs. fDSMP: 202±140), P>0.05. Participants in the eDSMP and fDSMP provided comparable high ratings of overall satisfaction with the respective programs (Table 4).
Table 4.
Satisfaction with eDSMP and fDSMP
| eDSMP | fDSMP | |
|---|---|---|
| (n=37) | (n=35) | |
| Starting the Study | ||
| Initial home visit by RN | 1.2±0.6 | 1.3±0.6 |
| Training on website | 1.4±0.6 | - |
| Training on smartphone | 3.4±1.7 | - |
| Communications | ||
| Ongoing communication with RN | 1.2±0.8 | 1.3±0.4 |
| (email) | (telephone) | |
| Posting messages to discussion board | 2.2±1.1 | - |
| Reading messages from discussion board | 1.8±0.9 | - |
| Education | ||
| Education modules | 1.9±0.8 | 1.6±0.7 |
| (web interactive) | (paper) | |
| Chats on strategies to manage SOB | 2.0±1.1 | - |
| Interacting with RN during education sessions | 1.9±1.1 | 1.3±0.6 |
| (live chats) | (face to face) | |
| Interacting with other participants during education sessions | 2.3±1.2 | 1.9±1.0 |
| (live chats) | (face to face) | |
| Exercise Monitoring | ||
| Setting exercise goals | 1.7±0.8 | 1.7±1.0 |
| Reviewing exercise progress on website | 2.0±0.9 | - |
| Recording daily exercises on website | 1.9±1.1 | - |
| Recording daily exercises on smartphone | 3.8±1.6 | - |
| Recording daily exercises on paper logs | - | 2.1±1.1 |
| Symptom Monitoring | ||
| Reviewing symptom graphs on website | 2.2±1.1 | - |
| Recording daily symptoms on website | 2.1±1.1 | - |
| Recording daily symptoms on smartphone | 4.0±1.5 | - |
| Recording daily symptoms on paper logs | - | 2.2±1.1 |
| Overall satisfaction with program | 1.2±0.4 | 1.4±0.7 |
Response scale: 1= Very helpful to 4=Not at all
Discussion
We found that the improvement in dyspnea with activities for both dyspnea self-management programs (fDSMP and eDSMP) were not significantly different from that of the health education control (GHE). However, participants in both DSMPs showed some improvements in dyspnea with activities over the course of 12 months, whereas the GHE participants did not. Individuals in both DSMPs also had greater improvements in self-efficacy for managing dyspnea and arm endurance compared with GHE, and perceived high levels of support for initiating and maintaining an exercise program. Although there was a trend for the DSMP participants to show improvements in exercise behavior, exercise performance, and HRQL, the changes were not large enough to be significantly different from GHE controls.
There are several possible explanations for the lack of differences in the change in dyspnea with activities between the DSMPs and GHE. First, participants in the DSMP groups may have been doing more activity with the same amount of dyspnea. It could be proposed that because participants in the DSMPs increased their physical activity as measured by a higher amount of exercise during the study, perceived a high level of support from the nurse coaches to start and maintain exercise, and had greater confidence in managing their dyspnea, reductions in dyspnea may not be the best target for this intervention. A recent study found that increasing physical activity without concurrent reductions in dyspnea severity was associated with better prognosis in patients with COPD.39 In addition, two other studies of technology-based interventions have shown positive effects on increasing or maintaining physical activity in patients with COPD.10, 12 These collective findings suggest that greater attention should be given to leveraging ICT to promote increased physical activity as a primary outcome in future studies because dyspnea intensity itself may not change.
Second, participants in this study reported relatively less dyspnea at baseline compared with samples from our previous studies despite a similar degree of airway obstruction.19, 21 A ceiling effect may have been present in this highly educated, activated, and technology-savvy sample, leaving little room for improvement. Alternatively, the general pattern of improvements in CRQ-D and other secondary outcomes for the DSMPs with little to no change in the GHE group suggests that perhaps with an adequately powered sample, we may have observed statistically significant group differences. In addition, the dyspnea instrument may not be sensitive to change. Participants in our previous studies were asked to rate the amount of dyspnea with activities that they selected versus the newer standardized approach that was used in the present study, where patients rated their dyspnea in response to five generic activities.29 This recent standardized CRQ has been reported to be less responsive to change compared with the original individualized version.40
Other possible reasons for the lack of group differences were treatment crossover by the GHE group and/or insufficient participation in the intervention by the DSMP participants. While we did not routinely document this, a number of the GHE participants who expressed disappointment with their group assignment vowed to seek other self-care resources. The significant improvements in their level of activation for self-care at three months (data not presented) may have reflected their positive attitudes and determination for self-care. Although DSMP participants reported high levels of satisfaction with the respective programs, only 26% met our a priori composite criteria for treatment exposure as defined in the per-protocol analysis.
The per-protocol criteria required at least 80% participation in all five DSMP components (completion of daily exercise/symptom logs, educational sessions, biweekly follow-up contacts, endurance and strengthening exercises). This meant that patients who did not participate in one of the five components were not included in the analysis even if they faithfully participated in the other four components. For example, patients who never experienced exacerbations or variations in their symptoms and did not see value in logging their symptoms on a daily basis but were engaged in the other intervention components were considered to have insufficient exposure to the DSMP. Although our criteria for treatment exposure is aligned with some of the published literature, we believe the criteria may be too stringent, especially for a complex intervention directed at a clinical population with heterogeneous needs.41 If the exposure criteria were relaxed, 50% of the participants would have met four of the five criteria and 69%, at least three criteria. Interestingly, for those DSMP participants who met the per-protocol criteria, improvements in dyspnea across the 12 months were clinically significant (CRQ-D >2.5 points) but did not meet the threshold of statistical significance when compared with GHE, likely the result of insufficient power. These collective findings reinforce the importance of risk stratification and individually tailoring complex self-management interventions to patient needs.
Another related factor influencing the level of participation in the DSMPs was participants’ preferences for use of various technologies to engage in the five intervention components. We did not specifically ask participants about their program preferences at any point during the study. However, after randomization, a number of participants expressed strong preferences for how they wanted to communicate with the nurse or participate in the group education/skills training sessions; the DSMP to which the patients were randomized was not always concordant with their preferences. Participants often desired a combination of eDSMP and fDSMP features. Our effort to maintain fidelity to the respective DSMPs was difficult at times, especially when patients chose not to participate in the in-person group sessions and/or only responded to phone calls instead of communicating via secure messaging.
Despite the aforementioned limitations, this study has several notable strengths including: a comprehensive assessment of multiple outcome domains; use of electronic data collection tools; and use of an attention control intervention, which few if any previous studies of self-management in COPD have included.42
Conclusions
The evidence base for using ICT to support self-management in older patients with COPD is still limited despite pervasive use of these tools in everyday life. This study provides additional data on the acceptability and efficacy of providing support for dyspnea self-management via ICT. The lack of group differences in the primary outcome of dyspnea with activities in this randomized trial should not dissuade the use of ICT to provide self-management support to patients with chronic conditions in the future. The improvements in selected secondary outcomes, such as increased confidence for managing dyspnea and exercise coupled with reports of high overall satisfaction, highlight the need for additional rigorous testing of a combination of face-to-face and technology-enabled approaches tailored to patient preferences in order to optimize patient engagement and consequently have a positive impact on modifiable and clinically relevant outcomes.
Acknowledgments
This work was support in part by R01 NR008938, UCSF & UW GCRCs (MO1-RR-000037 & MO1 RR-00079) and 1KL2RR025015, 1 UL1 RR025014. Dr. Reinke has funding through the Oncology Nursing Society and the Department of Veterans Affairs. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs.
Footnotes
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Disclosures
The authors express their heartfelt gratitude to all the study participants
The authors declare no conflicts of interest.
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