Clinical trial NCT01920243: 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
Overall status: COMPLETED
Phase: NA
Conditions: Injuries, Spinal Cord
Neurogenic Bowel
Urinary Bladder, Neurogenic
Keywords: Telemedicine
self-management
Medical psychology
Health psychology
Rehabilitation
Education, Health
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2013-08-09
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Spinal Cord Injury Quality of Life (SCI-QOL) Emotional Domain
timeFrame: Change from baseline at 6-month assessment
measure: SCI-QOL Physical Domain
timeFrame: Change from baseline at 6-month assessment
measure: SCI-QOL Social Domain
timeFrame: 6-month assessment
measure: Bowel and Bladder Treatment Index (BBTI)
timeFrame: Change from baseline at 6-month assessment
Secondary outcomes:
measure: Adapted version of the SCI Knowledge Questionnaire - SF
timeFrame: Change from baseline at 6-month assessment
measure: Social Problem Solving Inventory - Revised: Short Form (SPSI-R:S)
timeFrame: Change from baseline at 6-month assessment
measure: Appraisals of Disability: Primary and Secondary Scale (ADAPSS)
timeFrame: Change from baseline at 6-month assessment
measure: Disability Management Self Efficacy Scale (DMSES) - SF
timeFrame: Change from baseline at 6-month assessment
measure: Behavioral Adherence Assessment of Bladder and Bowel Treatment (BAABBT)
timeFrame: Change from baseline at 6-month assessment
measure: The Craig Handicap Assessment and Reporting Technique, Short Form (CHART-SF)
timeFrame: 6-month assessment
Other outcomes:
measure: Process Evaluation
timeFrame: 6-month assessment
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Spinal Cord Injury Model System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michelle A Meade, PhD
role: PRINCIPAL_INVESTIGATOR
References: