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A Tablet-based Simple Walking Intervention

Primary Purpose

Arthritis, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tab-CBI
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis focused on measuring arthritis, fatigue

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age >=50
  • has greater than minimal fatigue scoring ≥17 on the PROMIS Fatigue Short Form v1.0 Fatigue-8a.
  • self-reported diagnosis of Arthritis
  • having Wi-Fi at home.

Exclusion Criteria:

  • those who are currently engaging in regular exercise
  • non-ambulatory or having 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.)
  • overt delirium, dementia, or any conditions indicating deteriorating cognitive status as determined by the Mini-Cog

Sites / Locations

  • University of Massachusetts

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tab-CBI

Usual Care

Arm Description

The Tab-CBI group receives a tablet preloaded with the Tab-CBI application and an accelerometer. During the study period, the participants have four weekly educational sessions plus one booster session by the research assistant through a videoconferencing tool. The educational modules were developed based on the principles of cognitive behavioral therapy. The key elements of the modules include activity-pacing, adjustment of goal-setting to the current physical condition, setting priorities and structured planning of a simple walking activity and time off, and cognitive restructuring of activity demands (see attached, outline of education modules).

The usual care group receives Arthritis related fatigue management which are currently offered to the participants at the recruitment sites. Participant are also instructed to maintain usual activity during the study period. The control group participants also receive an accelerometer to count steps, but without a tablet.

Outcomes

Primary Outcome Measures

daily steps
daily step counts measured by an accelerometer
Fatigue severity
self-reported fatigue severity measured by PROMIS Fatigue-8a
perception of self-efficacy
self-reported self-efficacy measured by PROMIS Short Form v1.0 Self-Efficacy for Managing Symptoms-8a
perceived quality of life
self-reported perception of quality of life measured by WHOQOL

Secondary Outcome Measures

Full Information

First Posted
August 30, 2019
Last Updated
November 2, 2020
Sponsor
University of Massachusetts, Amherst
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1. Study Identification

Unique Protocol Identification Number
NCT04076358
Brief Title
A Tablet-based Simple Walking Intervention
Official Title
A Tablet-based Simple Walking Intervention to Improve Self-management of Arthritis Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Amherst

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this project is to pilot test the effect of a tablet-based cognitive behavioral intervention (Tab-CBI) application on older adults' a) daily steps, b) fatigue level, c) self-efficacy, and d) quality of life at Week 1 (baseline), Week 4 (intervention completion), Week 6 (booster), Week 8 (follow-up #1), and Week 10 (follow-up #2) in a sample of 24 older adults. The investigators hypothesize that (a) individuals receiving Tab-CBI will have increased daily step counts, decreased fatigue level, greater perception of self-efficacy and quality of life than those receiving current RA fatigue management, and that (b) the effects will be sustained up through 4 weeks of follow-ups after the intervention completion.
Detailed Description
The study uses an experimental pre- and post-test repeated measures design. After eligible participants sign an informed consent form, the participants will be screened for inclusion and exclusion criteria using two surveys (PROMIS Fatigue-8a, Mini-Cog) and verbally asking about age, presence of Arthritis diagnosis, Wi-Fi availability, engagement of regular exercise, presence of any non-ambulatory condition that limits walking. Those satisfying the inclusion and exclusion criteria are randomly assigned to the intervention (Tab-CBI, n=12) or comparison group (n=12). The Tab-CBI group receives a one-on-one introductory session which covers details about the study purpose and procedures, description of Tab-CBI, and instructions of how to operate a tablet, an accelerometer, and a videoconferencing tool. At the end of the session, participants are given a tablet preloaded with the Tab-CBI application and an accelerometer. During the study period, the participants will receive four weekly educational sessions plus one booster session at 2 weeks after the intervention conclusion. The educational modules were developed based on the principles of cognitive behavioral therapy. The key elements of the modules include activity-pacing, adjustment of goal-setting to the current physical condition, setting priorities and structured planning of a simple walking activity and time off, and cognitive restructuring of activity demands. Participants will record daily which steps taken by syncing the accelerometer to the tablet. The comparison group receives fatigue management which are currently offered to the patients and will be instructed to maintain usual activity during the study period. The control group participants also receive an accelerometer to count steps, but without a tablet. Participants in both groups take surveys for four outcomes (dally steps, fatigue, perceived self-efficacy, and perceived quality of life) and four potential covariate measures (pain, depression, sleep, and comorbidity) through a tablet computer (for intervention group) or paper-based surveys (for comparison group). Data are collected at Week 1 (baseline), Week 4 (intervention completion), Week 6 (booster), Week 8 (follow-up #1), and Week 10 (follow-up #2).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Fatigue
Keywords
arthritis, fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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-CBI, n=12) or comparison group (n=12).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tab-CBI
Arm Type
Experimental
Arm Description
The Tab-CBI group receives a tablet preloaded with the Tab-CBI application and an accelerometer. During the study period, the participants have four weekly educational sessions plus one booster session by the research assistant through a videoconferencing tool. The educational modules were developed based on the principles of cognitive behavioral therapy. The key elements of the modules include activity-pacing, adjustment of goal-setting to the current physical condition, setting priorities and structured planning of a simple walking activity and time off, and cognitive restructuring of activity demands (see attached, outline of education modules).
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The usual care group receives Arthritis related fatigue management which are currently offered to the participants at the recruitment sites. Participant are also instructed to maintain usual activity during the study period. The control group participants also receive an accelerometer to count steps, but without a tablet.
Intervention Type
Behavioral
Intervention Name(s)
Tab-CBI
Intervention Description
Participants receive a tablet preloaded with Tab-CBI application and an accelerometer.
Primary Outcome Measure Information:
Title
daily steps
Description
daily step counts measured by an accelerometer
Time Frame
24 hours
Title
Fatigue severity
Description
self-reported fatigue severity measured by PROMIS Fatigue-8a
Time Frame
past 1 week
Title
perception of self-efficacy
Description
self-reported self-efficacy measured by PROMIS Short Form v1.0 Self-Efficacy for Managing Symptoms-8a
Time Frame
24 hours
Title
perceived quality of life
Description
self-reported perception of quality of life measured by WHOQOL
Time Frame
past 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age >=50 has greater than minimal fatigue scoring ≥17 on the PROMIS Fatigue Short Form v1.0 Fatigue-8a. self-reported diagnosis of Arthritis having Wi-Fi at home. Exclusion Criteria: those who are currently engaging in regular exercise non-ambulatory or having 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.) overt delirium, dementia, or any conditions indicating deteriorating cognitive status as determined by the Mini-Cog
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeungok Choi, PhD
Organizational Affiliation
University of Massachusetts, Amherst
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Tablet-based Simple Walking Intervention

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