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

Primary Purpose

Injuries, Spinal Cord, Neurogenic Bowel, Urinary Bladder, Neurogenic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Mechanics Program
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injuries, Spinal Cord focused on measuring Telemedicine, self-management, Medical psychology, Health psychology, Rehabilitation, Education, Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Spinal Cord Injury Model System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Health Mechanics- New Injuries

Usual Care- New Injuries

Health Mechanics- Chronic Injuries

Usual Care- Chronics

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Adapted version of the SCI Knowledge Questionnaire - SF
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)
Measures four dimensions of problem solving: negative problem orientation, rational problem solving, impulsivity/carelessness and avoidance.
Appraisals of Disability: Primary and Secondary Scale (ADAPSS)
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
Measures perceived ability to manage SCI related tasks
Behavioral Adherence Assessment of Bladder and Bowel Treatment (BAABBT)
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)
Assessment of time spent performing a variety of activities in the home and community. This outcome will measure between group differences.

Full Information

First Posted
August 7, 2013
Last Updated
October 13, 2017
Sponsor
University of Michigan
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT01920243
Brief Title
Evaluation of a Bowel and Bladder Health Management Program for Individuals With Spinal Cord Injury (SCI)
Official Title
Applying Health Mechanics to Enhance Bowel and Bladder Health for Persons With SCI
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 28, 2013 (Actual)
Primary Completion Date
February 21, 2017 (Actual)
Study Completion Date
February 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Description
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Spinal Cord, Neurogenic Bowel, Urinary Bladder, Neurogenic
Keywords
Telemedicine, self-management, Medical psychology, Health psychology, Rehabilitation, Education, Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Mechanics- New Injuries
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care- New Injuries
Arm Type
No Intervention
Arm Description
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.
Arm Title
Health Mechanics- Chronic Injuries
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care- Chronics
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Mechanics Program
Other Intervention Name(s)
Health Mechanics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spinal Cord Injury Quality of Life (SCI-QOL) Emotional Domain
Description
The SCIQOL is administered via computerized adaptive testing forms and measures specific domains of health related quality of life relevant to living with SCI.
Time Frame
Change from baseline at 6-month assessment
Title
SCI-QOL Physical Domain
Description
The SCIQOL is administered via computerized adaptive testing forms and measures specific domains of health related quality of life relevant to living with SCI.
Time Frame
Change from baseline at 6-month assessment
Title
SCI-QOL Social Domain
Description
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.
Time Frame
6-month assessment
Title
Bowel and Bladder Treatment Index (BBTI)
Description
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.
Time Frame
Change from baseline at 6-month assessment
Secondary Outcome Measure Information:
Title
Adapted version of the SCI Knowledge Questionnaire - SF
Description
Adapted from Thietje et al. (2011) this measure assesses knowledge of bladder and bowel management
Time Frame
Change from baseline at 6-month assessment
Title
Social Problem Solving Inventory - Revised: Short Form (SPSI-R:S)
Description
Measures four dimensions of problem solving: negative problem orientation, rational problem solving, impulsivity/carelessness and avoidance.
Time Frame
Change from baseline at 6-month assessment
Title
Appraisals of Disability: Primary and Secondary Scale (ADAPSS)
Description
Measures six dimensions of appraisal: fearful despondency, overwhelming disbelief, determined resolve, growth and resilience, negative perceptions of disability, and personal agency.
Time Frame
Change from baseline at 6-month assessment
Title
Disability Management Self Efficacy Scale (DMSES) - SF
Description
Measures perceived ability to manage SCI related tasks
Time Frame
Change from baseline at 6-month assessment
Title
Behavioral Adherence Assessment of Bladder and Bowel Treatment (BAABBT)
Description
The difference between prescribed (by physician) and actual behaviors related specifically to bladder and bowel methods of management
Time Frame
Change from baseline at 6-month assessment
Title
The Craig Handicap Assessment and Reporting Technique, Short Form (CHART-SF)
Description
Assessment of time spent performing a variety of activities in the home and community. This outcome will measure between group differences.
Time Frame
6-month assessment
Other Pre-specified Outcome Measures:
Title
Process Evaluation
Description
Provides an opportunity for the participant to inform the research study team on his/her experience with the intervention and assessments.
Time Frame
6-month assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle A Meade, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Spinal Cord Injury Model System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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