A Telerehabilitation Intervention to Reduce the Impact of Fatigue in People With Congestive Heart Failure and Chronic Fatigue
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- East Carolina University
- Enrollment
- 23
- Primary Endpoint
- Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form Ver 1.0 Fatigue 8a
Study Overview
Brief Summary
This study compares the effectiveness of a 6-week Energy Conservation + Problem Solving Therapy Intervention to Health Education Intervention for reducing the fatigue impact and fatigue level and improving the level of participation in instrumental, leisure, and social activities in people with heart failure associated fatigue. Half of the participants received Energy Conservation + Problem Solving Therapy Intervention, and the other half received Health Education Intervention.
Detailed Description
Energy Conservation+Problem Solving Therapy (EC+PST) Intervention: In this study, the EC+PST Intervention will ideally occur twice a week for 6 weeks with each session lasting approximately 30 minutes. The intervention will be individually delivered via telehealth; therefore, participants will receive the intervention in their home to minimize fatigue from the intervention.
Health Education Intervention: The Health Education Intervention will occur once a week for 6 weeks with each session lasting approximately 30 minutes. The Health Education Intervention will be delivered via telehealth; therefore, participants will receive the intervention at their convenient quiet place to minimize fatigue from the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants are blinded to their group assignment. Assessors and interventionists were not blinded to the group assignment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(a) a minimum 6 months since diagnosed with HF and 3 months post-hospitalization, (b) reporting of moderate to severe fatigue by scoring ≥4 according to Fatigue Severity Scale, (c) living in the community, (d) having access to the internet or telephone in the place of residence, (e) having functional English fluency, and (f) having functional vision to operate the tablet computer.
Exclusion Criteria
- •had a score of ≥9 in Short Blessed Test indicating cognitive impairment
- •were classified as having New York Heart Association (NYHA) Functional Classification level IV on their medical record
Arms & Interventions
Energy Conservation plus Problem Solving Therapy Intervention
Receiving experimental intervention
Intervention: Energy Conservation plus Problem Solving Therapy (Other)
Health Education Intervention
Receiving control intervention
Intervention: Health Education Intervention (Other)
Outcomes
Primary Outcomes
Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form Ver 1.0 Fatigue 8a
Time Frame: Pretest (Week 0), Posttest (Week 7)
The PROMIS Fatigue 8a is a test measuring the experience and impact of fatigue. This assessment consists of 8 questions on fatigue experience and impact, and the raw score is converted to T-score (50% is the mean of the population). Higher the T-score, worse the fatigue.
Changes in Fatigue Impact Scale (FIS)
Time Frame: Pretest (Week 0), Posttest (Week 7)
The FIS is a 40-item measure that assesses the impact of fatigue on daily life in three different dimensions: Cognitive (10 items), Physical (10 items), and Psychosocial functioning (20 items). Each item is rated on a 5-point scale ranging from 0 (no problem) to 4 (extreme problem), and the global score is the sum of 40 items, ranging from 0 to 160.
Changes in Activity Card Sort (ACS)
Time Frame: Pretest (Week 0), Posttest (Week 7)
The ACS is a measure of the participation level in instrumental, leisure, and social activities. The ACS uses 89 photographs to calculate the percentage of retained activities since their diagnosis
Secondary Outcomes
No secondary outcomes reported
Investigators
Young Joo Kim
Assistant Professor
East Carolina University