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临床试验/NCT01920243
NCT01920243已完成不适用

Applying Health Mechanics to Enhance Bowel and Bladder Health for Persons With SCI

University of Michigan2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2013年10月28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
63
试验地点
2
主要终点
SCI-QOL Physical Domain

研究概览

简要总结

This study will look at the use of a telehealth version of a self management program in individuals with both new onset and chronic traumatic spinal cord injuries. The program is called Health Mechanics. It is meant to enhance self management skills related to neurogenic bladder and bowel management to prevent associated problems and improve Quality of Life (QOL). This program is based on the needs and strengths of individuals with SCI. It focuses on enhancing skills, encouraging positive health behaviors, empowering people within their own environments, and recognizing that people differ in their resources and abilities. The skills that are part of the intervention are: attitude, self-monitoring, problem-solving, communication, organization and stress management. This study will address those skills in the context of bladder and bowel health, with expectations that these skills to be useful in other areas of life as well.

The investigators hypothesize that individuals in the Health Mechanics intervention group will:

  • show greater improvements in problem solving skills, healthy attitudes about disability and knowledge of SCI management skills than will the control group
  • have greater adherence to recommended bladder and bowel management behaviors than the control group
  • have fewer bladder and bowel complications than the control group
  • have higher levels of QOL than the control group

In other words, this study will investigate the effectiveness of a telehealth version of Health Mechanics to enhance self-management skills related to neurogenic bladder and bowel management in an attempt to prevent associated complications and improve QOL.

详细描述

Background and Overview

This study will evaluate the efficacy of a newly developed self-management program, Health Mechanics, to develop and improve bladder and bowel management skills among persons with new and chronic SCI. Program participation is expected to prevent bladder and bowel related medical complications (e.g., constipation, leakage), leading to enhanced social participation and QOL. Health Mechanics was designed by the study PI, Dr. Meade, between 2007 and 2009 with funding from the Paralyzed Veteran's of America Education Foundation to assist persons with SCI develop and transfer the necessary skills to keep their bodies healthy while managing the many aspects of SCI care.

This study will investigate the effectiveness of a telehealth version of Health Mechanics to enhance self-management skills related to neurogenic bladder and bowel management in an attempt to prevent associated complications and improve QOL. The study makes a unique contribution to rehabilitation by emphasizing the concepts of personal responsibility and control over one's health and life as a whole. By selecting a telehealth approach (here defined as telephone-based) for program implementation, the investigators also attempt to address the high cost of care delivery and lack of health care access to underserved populations with SCI living in remote areas of the State of Michigan.

The Health Mechanics program is designed based on the needs and strengths of individuals with SCI while being responsive to identified gaps and challenges of health care provision in this population. The program focuses on enhancing skills, encouraging positive health behaviors and empowering people within their own environments, recognizing that people have different resources and abilities. For this study, the Health Mechanics program has been adapted to specifically focus on bladder and bowel management related concerns and to be administered via telephone, thus better addressing the needs of the rural population and transportation-related challenges.

By teaching skills to better manage bladder and bowel health, this self-management program should not only reduce the occurrence of complications but it should also result in higher levels of social integration and QOL. Since the skills taught - attitude, self-monitoring, problem-solving, communication, organization and stress management - will be addressed in the context of performing the behaviors necessary to enhance bladder and bowel health, we expect them to generalize into other areas such that improvements in these skills result in better overall health and participation.

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
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Usual Care- New Injuries

No Intervention

This group will not receive the intervention. They will receive usual care. This group will be comprised of individuals with new-onset traumatic spinal cord injuries.

Health Mechanics- New Injuries

Experimental

The Health Mechanics Program group receives the intervention. For this study, the Health Mechanics protocol is being applied to two areas of SCI management, bladder and bowel management, and administered over the telephone. The intervention will be administered as a series of modules delivered by a Health Coach (a health professional who works within the study team and is knowledgeable about SCI management). Individuals with new-onset traumatic spinal cord injuries are eligible for this group.

干预措施: Health Mechanics Program (Behavioral)

Health Mechanics- Chronic Injuries

Experimental

The Health Mechanics Program group receives the intervention. For this study, the Health Mechanics protocol is being applied to two areas of SCI management, bladder and bowel management, and administered over the telephone. The intervention will be administered as a series of modules delivered by a Health Coach (a health professional who works within the study team and is knowledgeable about SCI management). Individuals who have had traumatic spinal cord injuries for at least one year are eligible for this group.

干预措施: Health Mechanics Program (Behavioral)

Usual Care- Chronics

No Intervention

This group will not receive the intervention. They will receive usual care. This group will be comprised of individuals with who have had traumatic spinal cord injuries for at least one year.

结局指标

主要结局

SCI-QOL Physical Domain

时间窗: Change from baseline at 6-month assessment

The SCIQOL is administered via computerized adaptive testing forms and measures specific domains of health related quality of life relevant to living with SCI.

SCI-QOL Social Domain

时间窗: 6-month assessment

The SCIQOL is administered via computerized adaptive testing forms and measures specific domains of health related quality of life relevant to living with SCI. This outcome will measure between group differences.

Bowel and Bladder Treatment Index (BBTI)

时间窗: Change from baseline at 6-month assessment

The BBTI is a means for identification of the main method used for defecation as well as bladder management. It also measures complications and overall bowel and bladder health.

Spinal Cord Injury Quality of Life (SCI-QOL) Emotional Domain

时间窗: Change from baseline at 6-month assessment

The SCIQOL is administered via computerized adaptive testing forms and measures specific domains of health related quality of life relevant to living with SCI.

次要结局

  • Adapted version of the SCI Knowledge Questionnaire - SF(Change from baseline at 6-month assessment)
  • The Craig Handicap Assessment and Reporting Technique, Short Form (CHART-SF)(6-month assessment)
  • Disability Management Self Efficacy Scale (DMSES) - SF(Change from baseline at 6-month assessment)
  • Behavioral Adherence Assessment of Bladder and Bowel Treatment (BAABBT)(Change from baseline at 6-month assessment)
  • Social Problem Solving Inventory - Revised: Short Form (SPSI-R:S)(Change from baseline at 6-month assessment)
  • Appraisals of Disability: Primary and Secondary Scale (ADAPSS)(Change from baseline at 6-month assessment)

研究者

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

Michelle Meade

Associate Professor

University of Michigan

研究点 (2)

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