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

NCT ID: NCT04792853

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-21

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tab-G

Intervention Type BEHAVIORAL

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

Usual care group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tab-G

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

Intervention Type BEHAVIORAL

Other Intervention Names

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tablet-based group CBT education

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Amherst

OTHER

Sponsor Role lead

Responsible Party

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Jeungok Choi

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeungok Choi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Amherst

Locations

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University of Massachusetts

Amherst, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2130

Identifier Type: -

Identifier Source: org_study_id

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