A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue

January 27, 2020 updated by: Young Joo Kim, East Carolina University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Energy Conservation plus Problem Solving Therapy Intervention
Receiving experimental 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.
Active Comparator: Health Education Intervention
Receiving control intervention
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pretest (Week 0), Posttest (Week 7)
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.
Pretest (Week 0), Posttest (Week 7)
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
Pretest (Week 0), Posttest (Week 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2016

Primary Completion (Actual)

May 2, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

January 25, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCIRB 16-000078

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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