The goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to usual standard of care among 136 patients with COPD and/or HF. The main question it aims to answer is can this intervention promote physical activity as measured by daily step counts in sedentary patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive either the Mindful Steps intervention or usual care for 12 months, with both arms receiving a Walking for Health education booklet.
This is a 2-arm parallel remotely delivered RCT. A total of 136 participants with COPD and/or HF will be randomized in a 1:1 ratio to one of 2 arms in a pragmatic design: 1) Mindful Steps multi-modal intervention, or 2) usual care (including an education booklet on walking). Subjects will participate in the intervention for 12 months. Testing will occur at baseline, 3, 6, 12 (end intervention), and 15 months (post-intervention follow up) for all participants. Physical activity as measured by pedometer (i.e., daily step counts) at 12 months is the primary outcome to assess the efficacy of the Mindful Steps intervention. Secondary outcomes include cognitive-behavioral measures that may relate to behavior change in a conceptual model (self-efficacy, intrinsic motivation, mindful awareness/interoception) as well as patient-centered clinical outcomes (HRQL, dyspnea, fatigue, PA engagement, sedentary behavior).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
136
Integrated website, activity tracker, and mind-body training
VA Boston
Boston, Massachusetts, United States
RECRUITINGBIDMC
Boston, Massachusetts, United States
RECRUITINGChange in physical activity
Daily step counts will be measured as an objective proxy for physical activity using FitBit pedometers (FitBit Inspire 3)
Time frame: baseline, months 3, 6, 12, and 15
Change in self-efficacy
Exercise self-efficacy will be measured using the Self-Efficacy for Exercise Scale and the Self-Efficacy for Managing Chronic Disease Scale. The Self-Efficacy for Exercise Scale a 9-item validated scale; scores range from 9-28, with a higher score meaning more self-efficacy. The Self-Efficacy for Managing Chronic Disease Scale is a 6-item visual analog scale; scores range from 1-10, with a higher score indicating higher self-efficacy.
Time frame: baseline, months 3, 6, 12, and 15
Change in intrinsic motivation
Intrinsic motivation will be measured using the Intrinsic Motivation Inventory. This is a 22-item scale validated with four sub-scales: interest/enjoyment, perceived competence, perceived choice, and pressure/tension. A higher score is better, with a scoring range of 22-154.
Time frame: baseline, months 3, 6, 12, and 15
Qualitative inquiry
Half-hour semi-structured qualitative interviews guided by study staff will be conducted over video/phone in a random subset of 50 participants at the 6 and 12 month timepoints.
Time frame: months 6 and 12
Change in disease-specific quality-of-life
Disease-specific quality-of-life will be measured using St. George's Respiratory Questionnaire (SGRQ) and The Minnesota Living with Heart Failure Questionnaire (MLFHQ). The SGRQ is a 50-item instrument developed and validated in COPD and calculates four scores: symptomatology, activity, impacts and an overall metric; scores range from 0-100, with higher scores indicating more limitations. The MLFHQ is a 21-item instrument; total scores range from 0-105, with higher scores indicating poorer quality-of-life.
Time frame: baseline, months 3, 6, 12, and 15
Change in exercise engagement
Exercise engagement will be measured using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. This 41-item self-report questionnaire assesses engagement with physical activity, including frequency and duration, among older adults over the past 4 weeks. Separate scores are derived for physical activities of varying intensities. Frequency and estimated caloric expenditure are calculated per week for each of these physical activity categories, with higher scores indicating greater frequency and duration of exercise.
Time frame: baseline, months 3, 6, 12, and 15
Change in sedentary behaviors/time
Sedentary behaviors/time will be measured using online weekly exercise logs. These online weekly exercise logs will be used to assess frequency and categorize exercises.
Time frame: baseline, months 3, 6, 12, and 15
Change in dyspnea
Dyspnea is being measured using the UCSD Shortness of Breath Questionnaire - a 24 item questionnaire using a 6 point Likert scale; scores range from 0-120, with higher scores indicating greater dyspnea.
Time frame: baseline, months 3, 6, 12, and 15
Change in fatigue
Fatigue will be measured using the The Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 7a. Raw scores range from 7-35, and each raw score is translated into a standardized T-score, with higher T-scores representing greater fatigue.
Time frame: baseline, months 3, 6, 12 and 15
Change in mindful awareness
Mindful awareness will be measures using the Multidimensional Assessment of Interoceptive Awareness, consisting of 37 items (8 domains), each domain scored as the average score on a 6-point Likert.
Time frame: baseline, months 3, 6, 12 and 15
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