Clinical trial NCT03820674: A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue
Official title: A Telerehabilitation Intervention to Reduce the Impact of Fatigue in People With Congestive Heart Failure and Chronic Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Fatigue
Rehabilitation
Occupational Therapy
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both groups received 6-week interventions.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

1. had a score of ≥9 in Short Blessed Test indicating cognitive impairment
2. were classified as having New York Heart Association (NYHA) Functional Classification level IV on their medical record

Primary outcomes:
measure: Changes in Fatigue Impact Scale (FIS)
timeFrame: Pretest (Week 0), Posttest (Week 7)
measure: Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form Ver 1.0 Fatigue 8a
timeFrame: Pretest (Week 0), Posttest (Week 7)
measure: Changes in Activity Card Sort (ACS)
timeFrame: Pretest (Week 0), Posttest (Week 7)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kim YJ, Radloff JC, Crane PA, Bolin LP. Rehabilitation Intervention for Individuals With Heart Failure and Fatigue to Reduce Fatigue Impact: A Feasibility Study. Ann Rehabil Med. 2019 Dec;43(6):686-699. doi: 10.5535/arm.2019.43.6.686. Epub 2019 Dec 31.