A Tablet-based Simple Walking Intervention

NCT04076358 | Completed

• 1 other identifier: 2018-4832
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis; Fatigue

Keywords

arthritis, fatigue

Outcome Measures

Primary Outcomes (4)

• daily steps

  daily step counts measured by an accelerometer

  24 hours

• Fatigue severity

  self-reported fatigue severity measured by PROMIS Fatigue-8a

  past 1 week

• perception of self-efficacy

  self-reported self-efficacy measured by PROMIS Short Form v1.0 Self-Efficacy for Managing Symptoms-8a

  24 hours

• perceived quality of life

  self-reported perception of quality of life measured by WHOQOL

  past 2 weeks

Study Arms (2)

Tab-CBI

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Tab-CBI BEHAVIORAL

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

Tab-CBI

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead

Study Sites (1)

University of Massachusetts

Amherst, Massachusetts, 01003, United States

Location

MeSH Terms

Conditions

Arthritis; Fatigue

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeungok Choi, PhD

  University of Massachusetts, Amherst

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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).

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 3, 2019
• Study Start: May 23, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 18, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)