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临床试验/NCT05289544
NCT05289544已完成不适用

Evaluating Alternative Delivery Models for Arthritis Self-management Interventions

University of South Carolina1 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2022年4月1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
267
试验地点
1
主要终点
Change in Pain

研究概览

简要总结

The objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of Walk With Ease intervention.

详细描述

Participants will be randomized to either start the 6-week program immediately or after one year. Our Walk with Ease by Telephone (WWE-T) program is adapted from the original 6-week community-based group walking program developed by the Arthritis Foundation for adults with arthritis. The phone-based program will include 2 phone calls each week with a trained Walk With Ease Leader for 6 weeks. Assessments will be completed before at the start of the study, 6 weeks, 6 months and at 12 months.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, fibromyalgia
  • able to read and write in English
  • plan to live in the Columbia, SC region for next year
  • willing to be randomized to either group
  • complete all baseline measure

排除标准

  • contraindications to exercise (besides arthritis)
  • are pregnant, breastfeeding, or planning to become pregnant in the next year
  • have a serious cognitive impairment

研究组 & 干预措施

Phone-Based Walk With Ease Program

Experimental

Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program

干预措施: Phone-Based Walk With Ease (Behavioral)

Delayed Phone-Based Walk With Ease Program

Other

Telephone-Based Walk With Ease Program starting after the 1 year assessment

干预措施: Phone-Based Walk With Ease (Behavioral)

结局指标

主要结局

Change in Pain

时间窗: Baseline to 6 weeks

Visual analog scale (0mm no/low pain to 100 mm high pain)

Change in Pain

时间窗: Baseline to 6 months

Visual analog scale (0mm no/low pain to 100 mm high pain)

Change in Pain

时间窗: Baseline to 12 months

Visual analog scale (0mm no/low pain to 100 mm high pain)

Change in Physical Function - Chair Stands

时间窗: Baseline to 6 weeks

repetitions completed during 30 second chair stand test

Change in Physical Function - Chair Stands

时间窗: Baseline to 6 months

repetitions completed during 30 second chair stand test

Change in Physical Function - Chair Stands

时间窗: Baseline to 12 months

repetitions completed during 30 second chair stand test

Change in Physical Function - 6 Minute Walk

时间窗: Baseline to 6 weeks

Distance walked (ft) during 6 minute walk test

Change in Physical Function - 6 Minute Walk

时间窗: Baseline to 6 months

Distance walked (ft) during 6 minute walk test

Change in Physical Function - 6 Minute Walk

时间窗: Baseline to 12 months

Distance walked (ft) during 6 minute walk test

次要结局

  • Change in Physical Limitations(Baseline to 12 months)
  • Change in Physical Limitations(Baseline to 6 weeks)
  • Change in Physical Limitations(Baseline to 6 months)
  • Change in Physical Activity(Baseline to 6 weeks)
  • Change in Physical Activity(Baseline to 6 months)
  • Change in Physical Activity(Baseline to 12 months)
  • Change in Arthritis Management Self-efficacy(Baseline to 6 weeks)
  • Change in Arthritis Management Self-efficacy(Baseline to 6 months)
  • Change in Arthritis Management Self-efficacy(Baseline to 12 months)
  • Change in Blood Pressure(Baseline to 6 weeks)
  • Change in Blood Pressure(Baseline to 6 months)
  • Change in Blood Pressure(Baseline to 12 months)

研究者

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

Christine A Pellegrini, PhD

Assistant Professor

University of South Carolina

研究点 (1)

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