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临床试验/NCT03036189
NCT03036189已完成不适用

Improving Chronic Illness Management With the Apsaalooke Nation: The Baa Nnilah Project

Montana State University2 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2017年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
211
试验地点
2
主要终点
SF-12 - Physical Health

研究概览

简要总结

This is a group randomized trial of an intervention to improve chronic illness self-management.

研究设计

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

入排标准

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

入选标准

  • ≥ 25 years
  • diagnosed with diabetes
  • hypertension
  • osteoporosis
  • liver disease
  • chronic lung disease (asthma, chronic bronchitis or emphysema)
  • heart disease (coronary artery disease or congestive heart failure)
  • stroke (completed cerebrovascular accident with neurologic handicap and normal mentation)
  • chronic arthritis

排除标准

  • major medical illness that precludes their attendance at 7 meetings
  • <25 years of age

结局指标

主要结局

SF-12 - Physical Health

时间窗: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

The SF-12 is a set of 12 questions regarding function in physical and mental health domains. We changed question 2 to encapsulate moderate activities more applicable to our study population. Activities deleted were bowling and playing golf and activities added were carrying a small child, walking for exercise, or round dancing/push dancing (Native American traditional dances). Participants responded to questions about their physical and mental health, especially regarding the degree of limitation experienced, using varying response categories (i.e., 3, 5, or 6-point Likert scale, or yes/no format). A Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score were computed and normalized based on an algorithm developed by Farivar, Cunningham, and Hays (2007), which used an oblique factor solution for item weights. PCS and MCS scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, respectively.

SF-12 - Mental Health

时间窗: Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5)

The SF-12 is a set of 12 questions regarding function in physical and mental health domains. We changed question 2 to encapsulate moderate activities more applicable to our study population. Activities deleted were bowling and playing golf and activities added were carrying a small child, walking for exercise, or round dancing/push dancing (Native American traditional dances). Participants responded to questions about their physical and mental health, especially regarding the degree of limitation experienced, using varying response categories (i.e., 3, 5, or 6-point Likert scale, or yes/no format). A Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score were computed and normalized based on an algorithm developed by Farivar, Cunningham, and Hays (2007), which used an oblique factor solution for item weights. PCS and MCS scores range from 0 to 100, with higher scores indicating better physical and mental health functioning, respectively.

次要结局

  • Patient Health Questionnaire-9(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • PROMIS Self-Efficacy for Managing Symptoms(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • PROMIS Emotional Support(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • PROMIS Self-efficacy for Managing Emotions(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • PROMIS Physical Function(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • 6-minute Walk(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • PROMIS Satisfaction With Social Roles and Activities(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • PROMIS Positive Affect and Well-being(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • PROMIS Self-efficacy for Managing Social Interactions(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • Patient Activation Measure(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • Modified Timed Up and Go(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))
  • Modified Balance Error Scoring System(Intervention group: baseline (T1), up to 1 month (T2), up to 8 months (T3), up to 13 months (T4). WLC group pre-baseline (T1), baseline (T2), up to 1 month (T3), up to 9 months (T4), up to 13 months (T5))

研究者

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

Suzanne Held

Professor

Montana State University

研究点 (2)

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