Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04076358 |
| Other study ID # |
2018-4832 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 23, 2019 |
| Est. completion date |
March 18, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
University of Massachusetts, Amherst |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this project is to pilot test the effect of a tablet-based cognitive
behavioral intervention (Tab-CBI) application on older adults' a) daily steps, b) fatigue
level, c) self-efficacy, and d) quality of life at Week 1 (baseline), Week 4 (intervention
completion), Week 6 (booster), Week 8 (follow-up #1), and Week 10 (follow-up #2) in a sample
of 24 older adults.
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.
Description:
The study uses an experimental pre- and post-test repeated measures design. After eligible
participants sign an informed consent form, the participants will be screened for inclusion
and exclusion criteria using two surveys (PROMIS Fatigue-8a, Mini-Cog) and verbally asking
about age, presence of Arthritis diagnosis, Wi-Fi availability, engagement of regular
exercise, presence of any non-ambulatory condition that limits walking.
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).
