Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2019-05-23
2020-03-18
Brief Summary
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The investigators hypothesize that (a) individuals receiving Tab-CBI will have increased daily step counts, decreased fatigue level, greater perception of self-efficacy and quality of life than those receiving current RA fatigue management, and that (b) the effects will be sustained up through 4 weeks of follow-ups after the intervention completion.
Detailed Description
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Those satisfying the inclusion and exclusion criteria are randomly assigned to the intervention (Tab-CBI, n=12) or comparison group (n=12). The Tab-CBI group receives a one-on-one introductory session which covers details about the study purpose and procedures, description of Tab-CBI, and instructions of how to operate a tablet, an accelerometer, and a videoconferencing tool. At the end of the session, participants are given a tablet preloaded with the Tab-CBI application and an accelerometer. During the study period, the participants will receive four weekly educational sessions plus one booster session at 2 weeks after the intervention conclusion. The educational modules were developed based on the principles of cognitive behavioral therapy. The key elements of the modules include activity-pacing, adjustment of goal-setting to the current physical condition, setting priorities and structured planning of a simple walking activity and time off, and cognitive restructuring of activity demands. Participants will record daily which steps taken by syncing the accelerometer to the tablet.
The comparison group receives fatigue management which are currently offered to the patients and will be instructed to maintain usual activity during the study period. The control group participants also receive an accelerometer to count steps, but without a tablet.
Participants in both groups take surveys for four outcomes (dally steps, fatigue, perceived self-efficacy, and perceived quality of life) and four potential covariate measures (pain, depression, sleep, and comorbidity) through a tablet computer (for intervention group) or paper-based surveys (for comparison group). Data are collected at Week 1 (baseline), Week 4 (intervention completion), Week 6 (booster), Week 8 (follow-up #1), and Week 10 (follow-up #2).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Tab-CBI
The Tab-CBI group receives a tablet preloaded with the Tab-CBI application and an accelerometer. During the study period, the participants have four weekly educational sessions plus one booster session by the research assistant through a videoconferencing tool. The educational modules were developed based on the principles of cognitive behavioral therapy. The key elements of the modules include activity-pacing, adjustment of goal-setting to the current physical condition, setting priorities and structured planning of a simple walking activity and time off, and cognitive restructuring of activity demands (see attached, outline of education modules).
Tab-CBI
Participants receive a tablet preloaded with Tab-CBI application and an accelerometer.
Usual Care
The usual care group receives Arthritis related fatigue management which are currently offered to the participants at the recruitment sites. Participant are also instructed to maintain usual activity during the study period. The control group participants also receive an accelerometer to count steps, but without a tablet.
No interventions assigned to this group
Interventions
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Tab-CBI
Participants receive a tablet preloaded with Tab-CBI application and an accelerometer.
Eligibility Criteria
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Inclusion Criteria
* has greater than minimal fatigue scoring ≥17 on the PROMIS Fatigue Short Form v1.0 Fatigue-8a.
* self-reported diagnosis of Arthritis
* having Wi-Fi at home.
Exclusion Criteria
* non-ambulatory or having a condition that would limit the ability to walk (e.g., foot deformity, lower extremity joint surgery in past 6 months, stroke, severe chronic obstructive pulmonary disease, etc.)
* overt delirium, dementia, or any conditions indicating deteriorating cognitive status as determined by the Mini-Cog
50 Years
ALL
No
Sponsors
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University of Massachusetts, Amherst
OTHER
Responsible Party
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Jeungok Choi
Associate professor
Principal Investigators
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Jeungok Choi, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Amherst
Locations
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University of Massachusetts
Amherst, Massachusetts, United States
Countries
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Other Identifiers
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2018-4832
Identifier Type: -
Identifier Source: org_study_id