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临床试验/NCT04076358
NCT04076358已完成不适用

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

University of Massachusetts, Amherst1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
daily steps

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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).

干预措施: Tab-CBI (Behavioral)

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.

结局指标

主要结局

daily steps

时间窗: 24 hours

daily step counts measured by an accelerometer

perceived quality of life

时间窗: past 2 weeks

self-reported perception of quality of life measured by WHOQOL

Fatigue severity

时间窗: past 1 week

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

perception of self-efficacy

时间窗: 24 hours

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeungok Choi

Associate professor

University of Massachusetts, Amherst

研究点 (1)

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