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Evaluation of a Bowel and Bladder Health Management Program for Individuals With Spinal Cord Injury (SCI)
NCT01920243 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Health Mechanics Program
Study Locations (1)
Michigan
- University of Michigan Spinal Cord Injury Model System — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-10-28 |
| Est. Completion | 2017-02-21 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01920243
The ClinicalTrials.gov registry entry for NCT01920243 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,126 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Urinary Bladder, Neurogenic appearing as the primary indexed condition, and to 1 intervention — of which Health Mechanics Program is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01920243 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01920243 about?
NCT01920243 is a clinical study titled "Evaluation of a Bowel and Bladder Health Management Program for Individuals With Spinal Cord Injury (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...
What is the current status of trial NCT01920243?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2013-10-28. Estimated completion is 2017-02-21.
What conditions does trial NCT01920243 study?
This clinical trial studies the following conditions: Urinary Bladder, Neurogenic, Neurogenic Bowel, Injuries, Spinal Cord. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01920243?
The interventions under investigation include: Health Mechanics Program (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01920243?
This trial is sponsored by University of Michigan, which has 1,126 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01920243 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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