Clinical Trial: Evaluation of a Bowel and Bladder Health Management Program for Individuals With Spinal Cord Injury (SCI)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary:

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 He
Sponsor: University of Michigan

Current Primary Outcome:

  • Spinal Cord Injury Quality of Life (SCI-QOL) Emotional Domain [ Time Frame: 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 Physical Domain [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adapted version of the SCI Knowledge Questionnaire - SF [ Time Frame: Change from baseline at 6-month assessment ]
    Adapted from Thietje et al. (2011) this measure assesses knowledge of bladder and bowel management
  • Social Problem Solving Inventory - Revised: Short Form (SPSI-R:S) [ Time Frame: Change from baseline at 6-month assessment ]
    Measures four dimensions of problem solving: negative problem orientation, rational problem solving, impulsivity/carelessness and avoidance.
  • Appraisals of Disability: Primary and Secondary Scale (ADAPSS) [ Time Frame: Change from baseline at 6-month assessment ]
    Measures six dimensions of appraisal: fearful despondency, overwhelming disbelief, determined resolve, growth and resilience, negative perceptions of disability, and personal agency.
  • Disability Management Self Efficacy Scale (DMSES) - SF [ Time Frame: Change from baseline at 6-month assessment ]
    Measures perceived ability to manage SCI related tasks
  • Behavioral Adherence Assessment of Bladder and Bowel Treatment (BAABBT) [ Time Frame: Change from baseline at 6-month assessment ]
    The difference between prescribed (by physician) and actual behaviors related specifically to bladder and bowel methods of management
  • The Craig Handicap Assessment and Reporting Technique, Short Form (CHART-SF) [ Time Frame: 6-month assessment ]
    Assessment of time spent performing a variety of activities in the home and community. This outcome will measure between group differences.


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: August 7, 2013
Date Started: October 28, 2013
Date Completion:
Last Updated: March 10, 2017
Last Verified: March 2017