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Clinical Trials/NCT04792853
NCT04792853
Completed
Not Applicable

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

University of Massachusetts, Amherst1 site in 1 country40 target enrollmentJanuary 21, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthritis
Sponsor
University of Massachusetts, Amherst
Enrollment
40
Locations
1
Primary Endpoint
daily steps
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 21, 2021
End Date
April 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jeungok Choi

Associate professor

University of Massachusetts, Amherst

Eligibility Criteria

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.

Outcomes

Primary Outcomes

daily steps

Time Frame: 24 hours

daily step counts measured by an accelerometer

Quality of Life-Rheumatoid Arthritis Scale

Time Frame: 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.

Self-Efficacy for Managing Chronic Disease 6-Item Scale

Time Frame: 24 hours

self-reported self-efficacy scale. Scores can range from 6 to 60, with higher scores indicating higher self-efficacy.

BRICS NINR PROMIS Fatigue Short Form 6a

Time Frame: 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.

Study Sites (1)

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