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A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Energy Conservation plus Problem Solving Therapy
Health Education Intervention
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Fatigue, Rehabilitation, Occupational Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Energy Conservation plus Problem Solving Therapy Intervention

    Health Education Intervention

    Arm Description

    Receiving experimental intervention

    Receiving control intervention

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 24, 2019
    Last Updated
    January 27, 2020
    Sponsor
    East Carolina University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03820674
    Brief Title
    A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue
    Official Title
    A Telerehabilitation Intervention to Reduce the Impact of Fatigue in People With Congestive Heart Failure and Chronic Fatigue
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 17, 2016 (Actual)
    Primary Completion Date
    May 2, 2018 (Actual)
    Study Completion Date
    May 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    East Carolina University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Heart Failure, Fatigue, Rehabilitation, Occupational Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Both groups received 6-week interventions.
    Masking
    Participant
    Masking Description
    Participants are blinded to their group assignment. Assessors and interventionists were not blinded to the group assignment.
    Allocation
    Randomized
    Enrollment
    23 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Energy Conservation plus Problem Solving Therapy Intervention
    Arm Type
    Experimental
    Arm Description
    Receiving experimental intervention
    Arm Title
    Health Education Intervention
    Arm Type
    Active Comparator
    Arm Description
    Receiving control intervention
    Intervention Type
    Other
    Intervention Name(s)
    Energy Conservation plus Problem Solving Therapy
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Health Education Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in Fatigue Impact Scale (FIS)
    Description
    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.
    Time Frame
    Pretest (Week 0), Posttest (Week 7)
    Title
    Changes in Patient-Reported Outcomes Measurement Information System (PROMIS) - Short Form Ver 1.0 Fatigue 8a
    Description
    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.
    Time Frame
    Pretest (Week 0), Posttest (Week 7)
    Title
    Changes in Activity Card Sort (ACS)
    Description
    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
    Time Frame
    Pretest (Week 0), Posttest (Week 7)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31918531
    Citation
    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.
    Results Reference
    derived

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    A Telerehabilitation Intervention for People With Heart Failure and Chronic Fatigue

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