A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue

NCT03820674 | Completed

• 1 other identifier: UMCIRB 16-000078
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

Heart Failure; Fatigue; Rehabilitation; Occupational Therapy

Outcome Measures

Primary Outcomes (3)

• Changes in Fatigue Impact Scale (FIS)

  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.

  Pretest (Week 0), Posttest (Week 7)

• Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form Ver 1.0 Fatigue 8a

  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.

  Pretest (Week 0), Posttest (Week 7)

• Changes in Activity Card Sort (ACS)

  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

  Pretest (Week 0), Posttest (Week 7)

Study Arms (2)

Energy Conservation plus Problem Solving Therapy Intervention

EXPERIMENTAL

Receiving experimental intervention

Other: Energy Conservation plus Problem Solving Therapy

Health Education Intervention

ACTIVE COMPARATOR

Receiving control intervention

Other: Health Education Intervention

Interventions

Energy Conservation plus Problem Solving Therapy OTHER

EC-PST is a client-centered intervention aiming to guide people with chronic fatigue to create their own solutions so that they can generalize those learned solutions and strategies to other fatigue-related problems even after completing the study participation. Some of the topics covered during the first two introductory sessions are facts regarding fatigue, budgeting and banking energy, and the introduction of EC+PST Intervention.

Energy Conservation plus Problem Solving Therapy Intervention

Health Education Intervention OTHER

The interventionist will be the PI, an occupational therapist (co-I), or OT graduate student who will be trained in the health education topics. During the Health Education sessions, participants will be educated on health-related topics relevant to CHF and EC strategies, although they will not learn how to apply the information to their daily life. Health Education Workbook containing information on the topics taught during the sessions will be provided during the Pretest visit and used throughout the Health Education sessions.

Health Education Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• 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

Sponsors & Collaborators

• East Carolina University: lead

Related Publications (1)

• 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.

  PMID: 31918531 DERIVED

MeSH Terms

Conditions

Heart Failure; Fatigue

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to their group assignment. Assessors and interventionists were not blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Both groups received 6-week interventions.

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 29, 2019
• Study Start: June 17, 2016
• Primary Completion: May 2, 2018
• Study Completion: May 1, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01