ArthritisNCT04792853
Tablet-based Cognitive Behavioral Intervention for Older Adults With Arthritis Fatigue
A study testing Tab-G in people with Arthritis and Fatigue, run by University of Massachusetts, Amherst at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- What is being tested?
- Tab-G
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts
Amherst, Massachusetts, 01003
About this study
Official title: Tablet-based Cognitive Behavioral Intervention: Comparison of Group vs. Individual CBT Education
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.
- Being tested
- Tab-G
- Keywords
- arthritis, fatigue, cognitive behavioral therapy, group education, older adults, tablet, simple walking
- Medical subject headings
- Arthritis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tab-GBehavioural
Also called tablet-based group CBT education
Participants receive a tablet preloaded with Tab-G application and an accelerometer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily steps
daily step counts measured by an accelerometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: past 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start21 Jan 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeungok Choi, University of Massachusetts, Amherst
- Investigators
- Jeungok Choi, PhD, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792853
- Sponsor's protocol ID
- 2130
- Status last verified
- May 2023
- First submitted
- 7 Mar 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tablet-based Cognitive Behavioral Intervention: Comparison of Group vs. Individual CBT Education
- ClinicalTrials.gov ID
- NCT04792853
- Acronym / sponsor ID
- 2130
- Keywords
- arthritis, fatigue, cognitive behavioral therapy, group education, older adults, tablet, simple walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Tab-G (tablet-based group CBT education) | Experimental | Behavioral: Tab-GTab-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. |
| 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tab-GAlso: tablet-based group CBT educationParticipants receive a tablet preloaded with Tab-G application and an accelerometer. | Behavioural | Tab-G (tablet-based group CBT education) |
Primary outcome
daily steps
Time frame: 24 hours
daily step counts measured by an accelerometer
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeungok Choi, PhD principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tab-G in people with Arthritis and Fatigue, run by University of Massachusetts, Amherst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily steps (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.