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

May 8, 2023 updated by: Jeungok Choi, University of Massachusetts, Amherst

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Amherst, Massachusetts, United States, 01003
        • University of Massachusetts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tab-G (tablet-based group CBT education)
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
Participants receive a tablet preloaded with Tab-G application and an accelerometer.
Other Names:
  • tablet-based group CBT education
No Intervention: Usual care group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
daily steps
Time Frame: 24 hours
daily step counts measured by an accelerometer
24 hours
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.
past 1 week
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.
24 hours
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.
past 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Amherst

Investigators

  • Principal Investigator: Jeungok Choi, PhD, University of Massachusetts, Amherst

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

March 7, 2021

First Submitted That Met QC Criteria

March 7, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2130

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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