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CompletedNCT04792853Updated May 9, 2023

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

An interventional study of Tab-G in Arthritis and Fatigue, sponsored by University of Massachusetts, Amherst. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by University of Massachusetts, Amherst · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Arthritis
  • Fatigue

Keywords

  • arthritis
  • fatigue
  • cognitive behavioral therapy
  • group education
  • older adults
  • tablet
  • simple walking
03

In context

Arthritis

3,555 studies on the registry are indexed under Arthritis; 313 are open to participants now.

This study's enrollment of 40 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

University of Massachusetts, Amherst is the lead sponsor of 48 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralTab-G

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

    Also known as: tablet-based group CBT education

06

What researchers measure

Primary outcomes

  1. daily steps

    daily step counts measured by an accelerometer

    Time frame: 24 hours

  2. 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.

    Time frame: past 1 week

  3. 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.

    Time frame: 24 hours

  4. 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.

    Time frame: past 4 weeks

07

Study locations

1 site
  • University of Massachusetts
    Amherst, Massachusetts 01003, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2021 to primary completion in Apr 2023, 27 months.

Of 352 non-industry interventional studies with no phase under Arthritis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's 27 months is close to that.

Counting every sponsor, half of 399 studies reached it within 26 months; a quarter within 11 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2021
First posted
Mar 11, 2021
StartActual
Jan 21, 2021
Primary completionActual
Apr 30, 2023
CompletionActual
Apr 30, 2023
Last update
May 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04792853
Lead sponsor
University of Massachusetts, Amherst
Responsible party
Jeungok Choi (Associate professor, University of Massachusetts, Amherst) — Principal investigator
First posted
Mar 11, 2021
Start date
Jan 21, 2021
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023
Last update
May 9, 2023

Study contacts

Jeungok Choi, PhD
principal investigator · University of Massachusetts, Amherst

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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