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 : Active, not recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Other: Energy Conservation plus Problem Solving Therapy Other: Health Education Intervention||Not Applicable|
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 (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Both groups received 6-week interventions.|
|Masking Description:||Participants are blinded to their group assignment. Assessors and interventionists were not blinded to the group assignment.|
|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|
|Estimated Study Completion Date :||May 1, 2019|
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.
- 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.
- 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.
- 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