Evaluation of a Bowel and Bladder Health Management Program for Individuals With Spinal Cord Injury (SCI)
NCT ID: NCT01920243
Last Updated: 2017-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2013-10-28
2017-02-21
Brief Summary
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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 Description
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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.
Purpose and Objectives
The proposed study's overall purpose is to evaluate the effects of Health Mechanics in preventing bladder and bowel complications and to improve QOL. The program specifically targets newly injured individuals for early prevention of complications, as well individuals with chronic injuries for later treatment and prevention of complications. Objectives are: 1) to improve self-management skills, including problem-solving, knowledge of health behaviors, and attitude about disability; 2) to increase adherence to recommended bladder and bowel management behaviors; 3) to improve bladder and bowel health and related QOL; and 4) to determine the extent that program improvements in terms of skills acquired are sustained over time. Short-term refers to 3 and 6 months assessments while long-term refers to the 12 month assessment. All hypotheses posit that, following the intervention, differences will exist such that participants in the Health Mechanics program will perform better than the control group (an assessment of between group differences) and that these differences will be sustained over time (an assessment of within and between group differences). It is expected that individuals with new injuries will improve over time regardless of group assignment, while individuals with chronic injuries are stabilized prior to admission to the study. Because of these naturally occurring differences in trajectory, we will be examining within and between group differences.
Research Hypotheses
H1: Program participants will show greater improvements in problem solving skills, healthy attitudes about disability and knowledge of SCI management skills than will the control group; these improvements will be sustained over time within and between groups.
H2: Program participants will have greater adherence to recommended bladder and bowel management behaviors than the control group; these improvements will be sustained over time within and between groups.
H3: Program participants will have fewer bladder and bowel complications than the members of the control group; these differences will be maintained over time within and between groups.
H4: Program participants will have higher levels of QOL than the control group; these differences will be sustained over time within and between groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Health Mechanics- New Injuries
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.
Health Mechanics Program
The intervention will consist of six modules that will address attitudes, self-monitoring, communication and organizational skills, problem solving skills and stress management as presented through the Health Mechanics program. These modules are designed to take place over 6 phone calls of approximately 45 minutes each. In order to provide flexibility for the participants, the quantity and duration of calls may vary depending on the extent that the participant completes the homework and the amount of time they need to learn the skill.
Usual Care- New Injuries
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.
No interventions assigned to this group
Health Mechanics- Chronic Injuries
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.
Health Mechanics Program
The intervention will consist of six modules that will address attitudes, self-monitoring, communication and organizational skills, problem solving skills and stress management as presented through the Health Mechanics program. These modules are designed to take place over 6 phone calls of approximately 45 minutes each. In order to provide flexibility for the participants, the quantity and duration of calls may vary depending on the extent that the participant completes the homework and the amount of time they need to learn the skill.
Usual Care- Chronics
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.
No interventions assigned to this group
Interventions
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Health Mechanics Program
The intervention will consist of six modules that will address attitudes, self-monitoring, communication and organizational skills, problem solving skills and stress management as presented through the Health Mechanics program. These modules are designed to take place over 6 phone calls of approximately 45 minutes each. In order to provide flexibility for the participants, the quantity and duration of calls may vary depending on the extent that the participant completes the homework and the amount of time they need to learn the skill.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* being at least 18 years old
* having neurogenic bowel and/or bladder
* being community-living
* English-speaking
* completing inpatient rehabilitation for new SCI at University of Michigan Health System
* having an SCI for at least one year before enrollment
* expressing moderate to occasional bowel and/or bladder issues on the secondary conditions scale with associated distress
Exclusion Criteria
* current episode of severe depression as evidenced by scoring 20 or higher on the PHQ-9
* current suicidality or suicidal ideation
18 Years
ALL
No
Sponsors
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U.S. Department of Education
FED
University of Michigan
OTHER
Responsible Party
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Michelle Meade
Associate Professor
Principal Investigators
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Michelle A Meade, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Spinal Cord Injury Model System
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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H133N110002 -2
Identifier Type: -
Identifier Source: org_study_id