Clinical trial NCT04076358: A Tablet-based Simple Walking Intervention
Official title: A Tablet-based Simple Walking Intervention to Improve Self-management of Arthritis Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Fatigue
Keywords: arthritis, fatigue
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study uses an experimental pre- and post-test repeated measures design. Those satisfying the inclusion and exclusion criteria are randomly assigned to the intervention (Tab-CBI, n=12) or comparison group (n=12).
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* age \>=50
* 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:

* those who are currently engaging in regular exercise
* 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

Primary outcomes:
measure: daily steps
timeFrame: 24 hours
measure: Fatigue severity
timeFrame: past 1 week
measure: perception of self-efficacy
timeFrame: 24 hours
measure: perceived quality of life
timeFrame: past 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Jeungok Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References: