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Table 3 Outcome measures and data collection time points by research aim

From: Study of adherence to exercise in heart failure: the HEART camp trial protocol

Variable

Measure description (data collection time points)

 

Baseline & screening

Demographic and clinical variables Tool

Demographic (e.g., race, gender, age, marital status)

Clinical data (e.g., ejection fraction or EF, medications, BMI, comorbidities)

Cardiopulmonary stress test

Determine suitability for exercise (no significant ischemia or arrhythmias)

Heart rate ranges and appropriate levels of exercise training

 

Primary outcome – Aim 1 (Baseline, 6, 12 and 18 months)

Adherence

 

Self-report

Exercise diary for self-report of sessions per week and minutes per session [56]

Heart rate monitor

Heart rate monitor (used as validation of self-reported exercise each week

 

Evaluation of intervention mechanisms – Aim 2 (Baseline, 6, 12 and 18 months)

Knowledge

Physical activity & heart disease I.Q. – developed by NHLBI [57] 12 true/false items testing knowledge of how physical activity affects the heart

Attitudes

Attitudes toward physical activity/exercise - 8 items measure negative attitudes toward physical activity and 6 items measure positive attitudes toward physical activity [58]

Self-efficacy

Barriers Self-Efficacy Scale (BARSE) – 13 item scale measures self-efficacy or confidence in exercise behavior [59];

Self-management

Physical Activity Self-Regulation Scale (PASR 12)

Self-monitoring (2 items), Goal setting (2 items), Eliciting social support (2 items), Reinforcements (2 items), Time management (2 items) and Relapse management (2 items) [60]

Social support

Revenson Support Scale

Problematic support (4 items) and Positive support (16 items) [61]

 

Health outcomes – Aim 3 (Baseline, 6, 12 and 18 months)

Physical function

6 Minute Walk Test (6 MWT) – Objective measure of functional capacity (sub-maximal). Distance walked in 6 minutes [62, 63]

Psychological function

PROMIS-29 Profile v1.0: Anxiety (4 item subscale), Depression (4 item subscale), Satisfaction with Social Role (4 item subscale) [64]

Symptoms

Dyspnea/Fatigue Scale – Measures the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace at which the task is performed, and the associated functional impairment in general activities as a result of the symptoms [65]

Quality of life

Kansas City Cardiomyopathy Questionnaire (KCCQ) – 23-item disease-specific measure of quality of life in heart failure [66, 67]

 

Qualitative data – Aim 5

Open-Ended questions

All subjects complete at baseline

All subjects at baseline

  Survey prior experience with exercise, expectations related to exercise and outcomes from participation

Open-ended comments on exercise diaries

All subjects complete each week of the study

All subjects each week

  What helped you to exercise this week? What made exercising a challenge this week? Other comments?

One-on-one interviews

Open-ended questions with probing (30 minutes)

with HC subjects

  Interviews completed at 3, 6, 12 and 18 months

  Survey subjects’ perceptions of their experience with exercise adherence (e.g., challenges with adherence, helpful strategies, difficulties)

One-on-one interviews with coaches

Open-ended questions with probing (every 6 months during active recruitment)

  Questions about perceptions of exercise adherence experiences, strategies/difficulties working with patients, assessments of intervention components, descriptions of the intervention process for each phase

One-on-one interviews with group session leaders

Open-ended questions with probing (every 6 months during active recruitment)

  Questions about perceptions of exercise adherence experiences, strategies/difficulties working with patients, assessments of intervention components, descriptions of the intervention process