Injuries, Spinal CordNCT01920243
Evaluation of a Bowel and Bladder Health Management Program for Individuals With Spinal Cord Injury (SCI)
A study testing Health Mechanics Program in people with Injuries, Spinal Cord and Neurogenic Bowel, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injuries, Spinal Cord, Neurogenic Bowel, Urinary Bladder, Neurogenic
- What is being tested?
- Health Mechanics Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2013to 21 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Spinal Cord Injury Model System
Ann Arbor, Michigan, 48109
About this study
Official title: Applying Health Mechanics to Enhance Bowel and Bladder Health for Persons With SCI
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:
Read more
- 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.
Read the 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.
- Being tested
- Health Mechanics Program
- Keywords
- Telemedicine, self-management, Medical psychology, Health psychology, Rehabilitation, Education, Health
- Medical subject headings
- Spinal Cord Injuries, Neurogenic Bowel, Urinary Bladder, Neurogenic, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Mechanics ProgramBehavioural
Also called Health Mechanics
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health Mechanics Program |
| 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- 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. Receives: Behavioral: Health Mechanics Program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 6-month assessment
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.
Measured: Change from baseline at 6-month assessment
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.
Measured: 6-month assessment
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.
Measured: Change from baseline at 6-month assessment
Secondary outcomes (6)
Adapted version of the SCI Knowledge Questionnaire - SF
Adapted from Thietje et al. (2011) this measure assesses knowledge of bladder and bowel management
Measured: Change from baseline at 6-month assessment
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.
Measured: Change from baseline at 6-month assessment
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.
Measured: Change from baseline at 6-month assessment
Disability Management Self Efficacy Scale (DMSES) - SF
Measures perceived ability to manage SCI related tasks
Measured: Change from baseline at 6-month assessment
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
Measured: Change from baseline at 6-month assessment
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.
Measured: 6-month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study start28 Oct 2013
- Primary completion21 Feb 2017
- Study completion21 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries, Spinal CordStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Michelle Meade, University of Michigan
- Investigators
- Michelle A Meade, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920243
- Sponsor's protocol ID
- H133N110002 -2
- Status last verified
- Oct 2017
- First submitted
- 7 Aug 2013
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Health Mechanics to Enhance Bowel and Bladder Health for Persons With SCI
- ClinicalTrials.gov ID
- NCT01920243
- Acronym / sponsor ID
- H133N110002 -2
- Keywords
- Telemedicine, self-management, Medical psychology, Health psychology, Rehabilitation, Education, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- 28 Oct 2013 (actual)
- Primary completion
- 21 Feb 2017 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Health Mechanics- New Injuries | Experimental | Behavioral: Health Mechanics ProgramThe 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. |
| 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- Chronic Injuries | Experimental | Behavioral: Health Mechanics ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- having a traumatic spinal cord injury
- being at least 18 years old
- having neurogenic bowel and/or bladder
- being community-living
- English-speaking
Key exclusion criteria (4 listed)
- cognitive deficits and psychiatric conditions that render persons unable to independently direct or perform their own care
- current episode of severe depression as evidenced by scoring 20 or higher on the PHQ-9
- current suicidality or suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Mechanics ProgramAlso: Health MechanicsThe 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. | Behavioural | Health Mechanics- Chronic Injuries, Health Mechanics- New Injuries |
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.
6 secondary outcomes
Adapted version of the SCI Knowledge Questionnaire - SF
Time frame: Change from baseline at 6-month assessment
Social Problem Solving Inventory - Revised: Short Form (SPSI-R:S)
Time frame: Change from baseline at 6-month assessment
Appraisals of Disability: Primary and Secondary Scale (ADAPSS)
Time frame: Change from baseline at 6-month assessment
Disability Management Self Efficacy Scale (DMSES) - SF
Time frame: Change from baseline at 6-month assessment
Behavioral Adherence Assessment of Bladder and Bowel Treatment (BAABBT)
Time frame: Change from baseline at 6-month assessment
The Craig Handicap Assessment and Reporting Technique, Short Form (CHART-SF)
Time frame: 6-month assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle A Meade, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Mechanics Program in people with Injuries, Spinal Cord and Neurogenic Bowel, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Injury Quality of Life (SCI-QOL) Emotional Domain (time frame: Change from baseline at 6-month assessment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.