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临床试验/NCT04792853
NCT04792853已完成不适用

Tablet-based Cognitive Behavioral Intervention: Comparison of Group vs. Individual CBT Education

University of Massachusetts, Amherst1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月21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
40
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 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.

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
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

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.

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.

干预措施: Tab-G (Behavioral)

结局指标

主要结局

daily steps

时间窗: 24 hours

daily step counts measured by an accelerometer

Self-Efficacy for Managing Chronic Disease 6-Item Scale

时间窗: 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

时间窗: 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.

BRICS NINR PROMIS Fatigue Short Form 6a

时间窗: 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.

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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