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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792853
• Other study ID #: 2130
• Status: Completed
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Fatigue

Intervention

Behavioral:
• Tab-G
Participants receive a tablet preloaded with Tab-G application and an accelerometer.

Locations

Country	Name	City	State
United States	University of Massachusetts	Amherst	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily steps	daily step counts measured by an accelerometer	24 hours
Primary	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
Primary	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
Primary	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