A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue

Heart Failure Clinical Trial

Official title:

A Telerehabilitation Intervention to Reduce the Impact of Fatigue in People With Congestive Heart Failure and Chronic Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820674
• Other study ID #: UMCIRB 16-000078
• Status: Completed
• Phase: N/A
• Start date: June 17, 2016
• Est. completion date: May 1, 2019

Study information

• Verified date: January 2020
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 1, 2019
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Heart Failure

Intervention

Other:
• Energy Conservation plus Problem Solving Therapy
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.
• Health Education Intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)