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

NCT01920243 | Completed DMC

• 1 other identifier: H133N110002 -2
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Telemedicine; self-management; Medical psychology; Health psychology; Rehabilitation; Education, Health

Outcome Measures

Primary Outcomes (4)

• 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.

  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

Secondary Outcomes (6)

• 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

Other Outcomes (1)

• Process Evaluation

  6-month assessment

Study Arms (4)

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.

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.

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.

Interventions

Health Mechanics Program BEHAVIORAL

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.

Also known as: Health Mechanics

Health Mechanics- Chronic Injuries; Health Mechanics- New Injuries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having a traumatic spinal cord injury
• being at least 18 years old
• having neurogenic bowel and/or bladder
• being community-living
• English-speaking
• completing inpatient rehabilitation for new SCI at University of Michigan Health System
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• U.S. Department of Education: collaborator

Study Sites (1)

University of Michigan Spinal Cord Injury Model System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Neurogenic Bowel; Urinary Bladder, Neurogenic; Health Education

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Michelle A Meade, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 9, 2013
• Study Start: October 28, 2013
• Primary Completion: February 21, 2017
• Study Completion: February 21, 2017
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

US (1)