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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL171287 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The proposed research seeks to determine whether virtual coaching and social support focusing on key social cognitive factors will be an effective strategy for maintaining physical activity (PA) after completing cardiac rehabilitation (CR). Despite the well-documented benefits of CR, only 15-50% of individuals continue to exercise 6 months after completing CR.4-6 Thus, after 36 sessions (typically 12 weeks), many patients are left without the support necessary to sustain physical activity (PA) and prevent adverse secondary cardiac events. Though previous research has explored interventions to sustain PA after CR, many studies have been lacking in a theoretical basis, objective measurement of PA, measurement, and analysis of psychosocial and social cognitive factors, and long-term impact on clinical outcomes. Low-cost, pragmatic approaches to maintaining PA after CR is urgently needed for older adults, and virtual technologies offer promising solutions to promote adherence to PA. The three specific aims of the project are to: 1) determine the effect of virtual coaching and social support on adherence to PA (measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise; 2) determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups; 2a) evaluate the extent to which psychosocial and social cognitive factors mediate the effect of the intervention on PA adherence; 3) examine differences in cardiovascular (CVD) risk factors (blood pressure, lipids, HbA1c, BMI) between groups.
The investigators propose a randomized clinical trial in which the "STRIVE" control group will receive the Trainerize mobile app for (1) daily self monitoring of exercise, blood pressure, and weight; (2) education via weekly text messages; and (3) assigned monthly videos on various health topics. The "STRIVE +" intervention group will receive the same app for self-monitoring and education via text messages as the control group PLUS individually-tailored virtual coaching with goal-setting and social support/networking. Our specific aims are to:
Aim 1: Determine the effect of virtual coaching and social support on adherence to physical activity (PA; measured by objective step counts) in the intervention vs. control groups; secondary measures will be amount of sedentary time, functional fitness, and self-reported exercise.
Hypothesis 1: The intervention group will have more PA steps and self-reported exercise, less sedentary time, and higher functional fitness compared to the control group.
Aim 2: Determine the effect of virtual coaching and social support on psychosocial and social cognitive factors in the intervention vs. control groups.
Hypothesis 2: The intervention group will have lower depression/loneliness and higher self-efficacy/perceived social support compared to the control group.
Aim 2a: Evaluate the extent to which psychosocial and social cognitive factors mediate the effect of the intervention on PA adherence. Hypothesis 3: Lower depression/loneliness and higher perceived social support will mediate the effect of the intervention on PA adherence.
Aim 3: Examine differences in CVD risk factors (blood pressure, lipids, HbA1c, BMI) between groups. H: The intervention group will have better control of risk factors at 6, 12, and 18 months compared to control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile App Alone | No Intervention | Mobile app control group. Exposure time will be similar between participants in both the intervention and control groups as both will have: (1) continuous access to the app for self-monitoring of exercise, blood pressure, and weight; (2) weekly "push" text messages with access to a library of educational content for learning that is self-paced on the app over 6 months; and (3) assigned 1 video per month on a variety of health topics related to older adults via the app that match exposure time (approximately 20-30 minutes) with the intervention group. The videos will be created or resourced from reputable organizations. The coach will send weekly short one-way messages on goals, self-management, etc. that the intervention group will also receive. The 1-way messages will be derived from a bank of 210 secondary prevention messages for CVD (PA, nutrition, stress management, heart disease facts, etc.). | |
| Mobile app + Social | Experimental | The intervention group will also receive Virtual coaching. The coach will evaluate goals, progress, facilitators (use of the buddy system) and challenges with an emphasis on forming healthy PA habits that will be sustained long-term over the life course. Social support: For the social support component, we will provide ground rules for communication (e.g., positive posts, use of "likes", comments, etc.). Groups will be comprised of 4-6 participants with consecutive recruitment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Coaching and social support | Behavioral | The investigators propose a randomized clinical trial (RCT) of a virtual coaching and social support intervention that integrates evidence- and theory-based approaches to build self-efficacy, self-regulation, and perceived social support after cardiac rehabilitation (CR) to improve physical activity, psychosocial, social cognitive, and clinical outcomes, delivered via a social networking platform (Trainerize). Our intervention will also include goal setting for exercise and tailored feedback by our qualified intervention team. |
| Measure | Description | Time Frame |
|---|---|---|
| Step counts | The primary outcome of step counts will be collected from the Fitbit. Baseline measurements will be compared to repeated measures over time. Patients will wear the Fitbit for the 1-week run-in period before randomization then will wear it for 2 weeks at the end of month 3 and again at the end of month 6. | At baseline, 3, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity, barriers and sedentary time: Rapid Assessment of Physical Activity scale | This 9-item questionnaire assesses self-reported physical activity (higher score indicates higher activity, scored 0-9) | Baseline, 3, 6, and 12 months |
| Physical Activity, barriers and sedentary time: Exercise Barriers Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac events and rehospitalization trends: Cardiac events | Number of occurrences of cardiac events (e.g., myocardial infarction, revascularization) collected via EMR/self-report | 3, 6, 12, and 18 months |
| Cardiac events and rehospitalization trends: Rehospitalizations |
Study population: We will recruit 286 older adults who are 55 years and older with qualifying diagnoses for cardiac rehabilitation (CR).
Inclusion Criteria:
Exclusion Criteria:
Participation in Phase III CR (optional extended CR after outpatient Phase II CR for those who pay out-of-pocket)
Cognitive impairment (per Mini-Cog assessment tool with score 0-2)
Lack of English or Spanish proficiency/literacy
Clinical conditions including:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia von Oppenfeld | Contact | 415-676-1153 | julia.vonoppenfeld@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Linda Park, PhD, NP | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15668354 | Background | Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. doi: 10.1161/01.CIR.0000151788.08740.5C. | |
| 10547176 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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This 14-item questionnaire assesses exercise barriers. (Higher score associated with more positive perceptions of exercise, scored 14-56) |
| Baseline, 3, 6, and 12 months |
| Physical Activity, barriers and sedentary time: Self-reported sedentary time | The modified 1-item International Physical Activity Questionnaire assesses self-reported sedentary time (minutes/hours per day) | Baseline, 3, 6, and 12 months |
| Functional fitness tests: sit-to-stand | Investigators will assess the functional fitness outcomes by performing the 1 min sit-to-stand test (number of times from sitting to standing and back again within 60 seconds) | Baseline, 3, 6, and 12 months |
| Functional fitness tests: 2 minute step test | Investigators will assess the functional fitness outcomes by performing the 2-minute step test (number of times knee raised to designated position within 2 minutes) | Baseline, 3, 6, and 12 months |
| Functional fitness tests: dumbbell curl test | We will assess the functional fitness outcomes by performing the dumbbell curl test (number of dumbbell curls within 30 seconds) | Baseline, 3, 6, and 12 months |
| Psychosocial factors: Depression | The 8-item Patient Health Questionnaire (PHQ-8) will be used to measure depressive symptoms (higher score associated worse depression, scored 0-24) | Baseline, 3, 6, and 12 months |
| Psychosocial factors: Loneliness | Social Isolation Short Form 4a survey (PROMIS) featuring 4 questions adapted from the 20-question UCLA Loneliness Scale (Higher score associated with greater feelings of loneliness/isolation, scored 4-20) | Baseline, 3, 6, and 12 months |
| Social cognitive factors: Self-efficacy | The 9-item Self-efficacy for Exercise scale uses components of Social Cognitive Theory (higher score associated higher self-efficacy, scored 0-90) | Baseline, 3, 6, and 12 months |
| Social cognitive factors: Self-regulation | The 12-item Physical Activity Self-Regulation scale (PASR-12) has 6 sub-scales including self-monitoring, goal-setting, eliciting social support, reinforcement, time management, and relapse prevention (higher score associated with higher self-regulation, scored 12-60) | Baseline, 3, 6, and 12 months |
| Social cognitive factors: Perceived social support | The 12-item Multidimensional Scale of Perceived Social Support includes 3 subscales: family, friends, and significant other (higher score associated with higher perceived social support, scored 12-84) | Baseline, 3, 6, and 12 months |
| CV risk factors: hyperlipidemia | Lipids assessed from blood test results from the electronic medical record (EMR) | Baseline, 3, 6, 12, and 18 months |
| CV risk factors: hypertension | Hypertension assessed from blood pressure results from the electronic medical record (EMR) | Baseline, 3, 6, 12, and 18 months |
| CV risk factors: diabetes | Hemoglobin A1c assessed from blood test results from the electronic medical record (EMR) | Baseline, 3, 6, 12, and 18 months |
| CV risk factors: obesity | BMI assessed from the electronic medical record (EMR) | Baseline, 3, 6, 12, and 18 months |
Number rehospitalizations (cardiac and non-cardiac causes) collected via EMR/self-report |
| 3, 6, 12, and 18 months |
| Background |
| Ades PA, Maloney A, Savage P, Carhart RL Jr. Determinants of physical functioning in coronary patients: response to cardiac rehabilitation. Arch Intern Med. 1999 Oct 25;159(19):2357-60. doi: 10.1001/archinte.159.19.2357. |
| 26764059 | Background | Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044. |
| 9187980 | Background | Hellman EA. Use of the stages of change in exercise adherence model among older adults with a cardiac diagnosis. J Cardiopulm Rehabil. 1997 May-Jun;17(3):145-55. doi: 10.1097/00008483-199705000-00001. |
| 16472039 | Background | Moore SM, Charvat JM, Gordon NH, Pashkow F, Ribisl P, Roberts BL, Rocco M. Effects of a CHANGE intervention to increase exercise maintenance following cardiac events. Ann Behav Med. 2006 Feb;31(1):53-62. doi: 10.1207/s15324796abm3101_9. |
| 34473064 | Background | Elnaggar A, von Oppenfeld J, Whooley MA, Merek S, Park LG. Applying Mobile Technology to Sustain Physical Activity After Completion of Cardiac Rehabilitation: Acceptability Study. JMIR Hum Factors. 2021 Sep 2;8(3):e25356. doi: 10.2196/25356. |
| 30143472 | Background | Stafford M, von Wagner C, Perman S, Taylor J, Kuh D, Sheringham J. Social connectedness and engagement in preventive health services: an analysis of data from a prospective cohort study. Lancet Public Health. 2018 Sep;3(9):e438-e446. doi: 10.1016/S2468-2667(18)30141-5. Epub 2018 Aug 22. |
| 28880099 | Background | Holt-Lunstad J, Robles TF, Sbarra DA. Advancing social connection as a public health priority in the United States. Am Psychol. 2017 Sep;72(6):517-530. doi: 10.1037/amp0000103. |