A Tablet-based Simple Walking Intervention

November 2, 2020 updated by: Jeungok Choi, University of Massachusetts, Amherst

A Tablet-based Simple Walking Intervention to Improve Self-management of Arthritis Fatigue

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Amherst, Massachusetts, United States, 01003
        • University of Massachusetts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Tab-CBI
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).
Behavioral: Tab-CBI
Participants receive a tablet preloaded with Tab-CBI application and an accelerometer.
NO_INTERVENTION: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
daily steps
Time Frame: 24 hours
daily step counts measured by an accelerometer
24 hours
Fatigue severity
Time Frame: past 1 week
self-reported fatigue severity measured by PROMIS Fatigue-8a
past 1 week
perception of self-efficacy
Time Frame: 24 hours
self-reported self-efficacy measured by PROMIS Short Form v1.0 Self-Efficacy for Managing Symptoms-8a
24 hours
perceived quality of life
Time Frame: past 2 weeks
self-reported perception of quality of life measured by WHOQOL
past 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Amherst

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-4832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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