Tablet-based Cognitive Behavioral Intervention for Older Adults With Arthritis Fatigue

Not Applicable

Completed

• Conditions: Fatigue; Arthritis
• Interventions: Behavioral: Tab-G

• Registration Number: NCT04792853
• Lead Sponsor: University of Massachusetts, Amherst

Brief Summary

The purpose of this project is to pilot test a long-term effect of Tab-G (tablet-based cognitive behavioral group education intervention). The investigators will evaluate the effect of Tab-G, relative to usual care group, on (a) daily steps, (b) fatigue level, (c) self-efficacy and (d) quality of life.

Tab-G participants will receive 4 weekly CBT-based group education focusing on shared goal setting and mutual reinforcement in a group with 5 members. The outcomes will be measured baseline, week 4 (intervention completion) and week 8 (follow-up). The investigators hypothesize that older adults receiving Tab-G will have greater improvements on outcomes compared to those receiving usual care at week 4, the intervention completion and at week 8 follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-21
• Study First Submitted: 2021-03-07
• Study First Submitted QC: 2021-03-07
• Study First Posted: 2021-03-11
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. diagnosis of osteoarthritis or rheumatoid arthritis;
2. presence of greater than minimal fatigue scoring ≥13 (T-score>55) on the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0-Fatigue 6a; and
3. having Wi-Fi at home

Exclusion Criteria

1. currently engaging in regular exercise;
2. non-ambulatory or presence of 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.); and
3. delirium, dementia, or any conditions indicating deteriorating cognitive status as determined by the Mini-Cog.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tab-G (tablet-based group CBT education)	Tab-G	Tab-G participants will receive 4 weekly CBT(cognitive behavioral therapy)-based group learning sessions to encourage a simple walking activity through videoconferencing meetings in a group of 5 members. The educational materials emphasize shared goal setting and mutual reinforcement.

Primary Outcome Measures

Name	Time	Method
daily steps	24 hours	daily step counts measured by an accelerometer
Self-Efficacy for Managing Chronic Disease 6-Item Scale	24 hours	self-reported self-efficacy scale. Scores can range from 6 to 60, with higher scores indicating higher self-efficacy.
Quality of Life-Rheumatoid Arthritis Scale	past 4 weeks	self-reported perception of quality of life. Scores can range from 8 to 80 with higher scores indicating greater quality of life.
BRICS NINR PROMIS Fatigue Short Form 6a	past 1 week	self-reported fatigue scale measuring both the experience of fatigue and the interference of fatigue on daily activities. Scores can range from 6 to 30, with higher scores indicating greater fatigue.

Trial Locations

Locations (1)

University of Massachusetts; 🇺🇸 Amherst, Massachusetts, United States