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Completed

NCT Number: NCT04792853

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

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.

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Key information

Conditions

Arthritis Fatigue Joint Diseases Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts

Amherst, Massachusetts, 01003, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tab-G

Behavioral

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

Other names: tablet-based group CBT education

Primary outcomes

  1. daily steps

    Time frame: 24 hours

    daily step counts measured by an accelerometer

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Amherst

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 11, 2021
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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