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

Sponsor
University of Massachusetts, Amherst (Other)
Overall Status
Recruiting
CT.gov ID
NCT04792853
Collaborator
(none)
40
1
2
27.2
1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tab-G
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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)
Primary Purpose:
Supportive Care
Official Title:
Tablet-based Cognitive Behavioral Intervention: Comparison of Group vs. Individual CBT Education
Actual Study Start Date :
Jan 21, 2021
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. daily steps [24 hours]

      daily step counts measured by an accelerometer

    2. BRICS NINR PROMIS Fatigue Short Form 6a [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.

    3. Self-Efficacy for Managing Chronic Disease 6-Item Scale [24 hours]

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

    4. Quality of Life-Rheumatoid Arthritis Scale [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Massachusetts Amherst Massachusetts United States 01003

    Sponsors and Collaborators

    • University of Massachusetts, Amherst

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeungok Choi, Associate professor, University of Massachusetts, Amherst
    ClinicalTrials.gov Identifier:
    NCT04792853
    Other Study ID Numbers:
    • 2130
    First Posted:
    Mar 11, 2021
    Last Update Posted:
    Apr 29, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jeungok Choi, Associate professor, University of Massachusetts, Amherst
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 29, 2022