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

NCT04792853 | Completed

• 1 other identifier: 2130
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis; Fatigue

Keywords

arthritis; fatigue; cognitive behavioral therapy; group education; older adults; tablet; simple walking

Outcome Measures

Primary Outcomes (4)

• daily steps

  daily step counts measured by an accelerometer

  24 hours

• 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

• 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

• 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

Study Arms (2)

Tab-G (tablet-based group CBT education)

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

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

Interventions

Tab-G BEHAVIORAL

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

Also known as: tablet-based group CBT education

Tab-G (tablet-based group CBT education)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead

Study Sites (1)

University of Massachusetts

Amherst, Massachusetts, 01003, United States

Location

MeSH Terms

Conditions

Arthritis; Fatigue

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeungok Choi, PhD

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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).

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 11, 2021
• Study Start: January 21, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

US (1)