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Applying Health Mechanics to Enhance Bowel and Bladder Health for Persons With SCI
Sponsor study identifier
interventional
63
1 country
1
Study Start
October 28, 2013
Actual (reported)Primary Completion
February 21, 2017
Actual (reported)Study Completion
February 21, 2017
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 21, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 7, 2013
Actual (reported)August 9, 2013
Actual (reported)October 28, 2013
Actual (reported)February 21, 2017
Actual (reported)February 21, 2017
Actual (reported)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.
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.
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.
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 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Michigan Spinal Cord Injury Model System
Ann Arbor, Michigan, 48109, United States
Michelle A Meade, PhD
University of Michigan
63 participants (actual enrollment reported by the registry).
First Submitted
August 7, 2013
First Posted
August 9, 2013
Study Start
October 28, 2013
Actual (reported)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.
Change from baseline at 6-month assessment
Adapted version of the SCI Knowledge Questionnaire - SF
Change from baseline at 6-month assessment
Social Problem Solving Inventory - Revised: Short Form (SPSI-R:S)
Change from baseline at 6-month assessment
Appraisals of Disability: Primary and Secondary Scale (ADAPSS)
Change from baseline at 6-month assessment
Disability Management Self Efficacy Scale (DMSES) - SF
Change from baseline at 6-month assessment
Behavioral Adherence Assessment of Bladder and Bowel Treatment (BAABBT)
Change from baseline at 6-month assessment
Process Evaluation
6-month assessment
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.
Contact the study team to confirm eligibility.
Primary Completion
February 21, 2017
Actual (reported)Study Completion
February 21, 2017
Actual (reported)Last Updated
October 17, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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