Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820674
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Young Joo Kim, East Carolina University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Energy Conservation plus Problem Solving Therapy Other: Health Education Intervention Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Both groups received 6-week interventions.
Masking: Single (Participant)
Masking Description: Participants are blinded to their group assignment. Assessors and interventionists were not blinded to the group assignment.
Primary Purpose: Treatment
Official Title: A Telerehabilitation Intervention to Reduce the Impact of Fatigue in People With Congestive Heart Failure and Chronic Fatigue
Actual Study Start Date : June 17, 2016
Actual Primary Completion Date : May 2, 2018
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Young Joo Kim, Assistant Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT03820674    
Other Study ID Numbers: UMCIRB 16-000078
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Young Joo Kim, East Carolina University:
Heart Failure
Fatigue
Rehabilitation
Occupational Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Fatigue
Heart Diseases
Cardiovascular Diseases