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

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ClinicalTrials.gov Identifier: NCT01920243
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Michelle Meade, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Injuries, Spinal Cord Neurogenic Bowel Urinary Bladder, Neurogenic Behavioral: Health Mechanics Program Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Applying Health Mechanics to Enhance Bowel and Bladder Health for Persons With SCI
Actual Study Start Date : October 28, 2013
Actual Primary Completion Date : February 21, 2017
Actual Study Completion Date : February 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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 Name: Health Mechanics

No Intervention: 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.
Experimental: 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.
Behavioral: 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 Name: Health Mechanics

No Intervention: 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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. Disability Management Self Efficacy Scale (DMSES) - SF [ Time Frame: Change from baseline at 6-month assessment ]
    Measures perceived ability to manage SCI related tasks

  5. 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

  6. 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.


Other Outcome Measures:
  1. Process Evaluation [ Time Frame: 6-month assessment ]
    Provides an opportunity for the participant to inform the research study team on his/her experience with the intervention and assessments.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for all groups:

  • having a traumatic spinal cord injury
  • being at least 18 years old
  • having neurogenic bowel and/or bladder
  • being community-living
  • English-speaking

Additional inclusion criteria for new injury onset groups:

  • completing inpatient rehabilitation for new SCI at University of Michigan Health System

Additional inclusion criteria for chronic injury groups:

  • 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 for all groups:

  • cognitive deficits and psychiatric conditions that render persons unable to independently direct or perform their own care

Additional Exclusion Criteria for chronic injury groups:

  • current episode of severe depression as evidenced by scoring 20 or higher on the PHQ-9
  • current suicidality or suicidal ideation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920243


Locations
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United States, Michigan
University of Michigan Spinal Cord Injury Model System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
U.S. Department of Education
Investigators
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Principal Investigator: Michelle A Meade, PhD University of Michigan

Additional Information:
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Responsible Party: Michelle Meade, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01920243     History of Changes
Other Study ID Numbers: H133N110002 -2
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017

Keywords provided by Michelle Meade, University of Michigan:
Telemedicine
self-management
Medical psychology
Health psychology
Rehabilitation
Education, Health

Additional relevant MeSH terms:
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Neurogenic Bowel
Urinary Bladder, Neurogenic
Spinal Cord Injuries
Spinal Injuries
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Back Injuries