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

Primary Purpose

Arthritis, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tab-G
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis focused on measuring arthritis, fatigue, cognitive behavioral therapy, group education, older adults, tablet, simple walking

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Massachusetts

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tab-G (tablet-based group CBT education)

Usual care group

Arm Description

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.

A usual care group will receive general arthritis management education. Participant are instructed to maintain usual activity during the study period.

Outcomes

Primary Outcome Measures

daily steps
daily step counts measured by an accelerometer
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2021
Last Updated
May 8, 2023
Sponsor
University of Massachusetts, Amherst
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1. Study Identification

Unique Protocol Identification Number
NCT04792853
Brief Title
Tablet-based Cognitive Behavioral Intervention for Older Adults With Arthritis Fatigue
Official Title
Tablet-based Cognitive Behavioral Intervention: Comparison of Group vs. Individual CBT Education
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Amherst

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Fatigue
Keywords
arthritis, fatigue, cognitive behavioral therapy, group education, older adults, tablet, simple walking

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tab-G (tablet-based group CBT education)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
A usual care group will receive general arthritis management education. Participant are instructed to maintain usual activity during the study period.
Intervention Type
Behavioral
Intervention Name(s)
Tab-G
Other Intervention Name(s)
tablet-based group CBT education
Intervention Description
Participants receive a tablet preloaded with Tab-G application and an accelerometer.
Primary Outcome Measure Information:
Title
daily steps
Description
daily step counts measured by an accelerometer
Time Frame
24 hours
Title
BRICS NINR PROMIS Fatigue Short Form 6a
Description
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.
Time Frame
past 1 week
Title
Self-Efficacy for Managing Chronic Disease 6-Item Scale
Description
self-reported self-efficacy scale. Scores can range from 6 to 60, with higher scores indicating higher self-efficacy.
Time Frame
24 hours
Title
Quality of Life-Rheumatoid Arthritis Scale
Description
self-reported perception of quality of life. Scores can range from 8 to 80 with higher scores indicating greater quality of life.
Time Frame
past 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeungok Choi, PhD
Organizational Affiliation
University of Massachusetts, Amherst
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01003
Country
United States

12. IPD Sharing Statement

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

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