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

Study Overview
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Brief Summary
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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.

Official Title
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Tablet-based Cognitive Behavioral Intervention: Comparison of Group vs. Individual CBT Education

Conditions
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Arthritis, Fatigue

Intervention / Treatment
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* Behavioral: Tab-G


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of osteoarthritis or rheumatoid arthritis; 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 having Wi-Fi at home Exclusion Criteria: currently engaging in regular exercise; 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 delirium, dementia, or any conditions indicating deteriorating cognitive status as determined by the Mini-Cog.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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-G, n=20) or comparison group (n=20).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tab-G (tablet-based group CBT education)<br>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. | Behavioral: Tab-G<br>* Participants receive a tablet preloaded with Tab-G application and an accelerometer.<br>* Other names: tablet-based group CBT education;|
| No Intervention: Usual care group<br>A usual care group will receive general arthritis management education. Participant are instructed to maintain usual activity during the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily steps | daily step counts measured by an accelerometer | 24 hours | 
| BRICS NINR PROMIS Fatigue Short Form 6a | 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. | past 1 week | 
| Self-Efficacy for Managing Chronic Disease 6-Item Scale | self-reported self-efficacy scale. Scores can range from 6 to 60, with higher scores indicating higher self-efficacy. | 24 hours | 
| Quality of Life-Rheumatoid Arthritis Scale | self-reported perception of quality of life. Scores can range from 8 to 80 with higher scores indicating greater quality of life. | past 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthritis, fatigue, cognitive behavioral therapy, group education, older adults, tablet, simple walking