Summary

Eligibility
for people ages 55-100 (full criteria)
Location
at San Francisco 5391959, California 5332921
Dates
study started
study ends around
Principal Investigator
by Linda Park, PhD, NP
Headshot of Linda Park
Linda Park

Description

Summary

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.

Official Title

Supportive Training After Cardiac Rehabilitation Including Virtual Engagement: The STRIVE Study

Details

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.

Keywords

Adherence to Physical Activity After Completing Cardiac Rehabilitation (CR) in Older Adults, Cardiac rehabilitation, Adherence, Cardiovascular disease, m-Health, Physical Activity, Social support, Cardiovascular Diseases, Motor Activity, Virtual Coaching and social support, Mobile App Alone, Mobile app + Social

Eligibility

For people ages 55-100

Study population: We will recruit 286 older adults who are 55 years and older with qualifying diagnoses for cardiac rehabilitation (CR).

Inclusion Criteria:

  1. ≥ 55 years of age
  2. History of CVD that qualified patient for CR (myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, heart failure, valve replacement, etc.)
  3. Adherence (>50% of sessions for ≥1 month) to outpatient Phase II CR and pending completion

Exclusion Criteria:

  1. Participation in Phase III CR (optional extended CR after outpatient Phase II CR for those who pay out-of-pocket)
  2. Cognitive impairment (per Mini-Cog assessment tool with score 0-2)
  3. Lack of English or Spanish proficiency/literacy
  4. Clinical conditions including:
    1. Unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm or symptomatic anemia
    2. Active infection
    3. Uncontrolled hypertension: resting systolic >180 mmHg, diastolic >100 mmHg
    4. Decompensated heart failure, NYHA Class III-IV
    5. Current unstable angina
    6. 2nd or 3rd degree heart block or exercise induced arrhythmias

Location

  • UCSF accepting new patients
    San Francisco 5391959 California 5332921 94143 United States

Lead Scientist at UCSF

  • Linda Park, PhD, NP
    Dr. Park's program of research focuses on the secondary prevention of cardiovascular disease. Her current research projects center around determining the most engaging, practical, and meaningful technology-based interventions to improve patient self-care, clinical outcomes, and quality of life for patients with ischemic heart disease and heart failure.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Related Info
ID
NCT06701188
Study Type
Interventional
Participants
Expecting 286 study participants
Last Updated