POWERS-TBI: A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT04288258
Collaborator
(none)
40
1
1
29
1.4

Study Details

Study Description

Brief Summary

To evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program on promoting healthy lifestyle behaviors and improving health outcomes.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Telehealth-Based Health and Wellness Program (POWERS-TBI)
N/A

Detailed Description

The purpose of this study is to evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program (POWERS-TBI) on promoting healthy lifestyle behaviors and improving self-efficacy for healthy activities such as amount of physical activity, dietary/food intake, mental stimulation and activity, substance use, mindfulness/spirituality, social relationships, and/or leisure activities among persons with TBI and their caregivers. The treatment program will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse. The goals are to evaluate the impact of the treatment program on improving health outcomes for people with TBI. The investigators plan to accomplish this by evaluating the impact of the program using a case-control crossover design.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
case-control crossovercase-control crossover
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury (TBI) and Their Caregivers: In-House Research Project, Objective 2
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Health and Wellness Program

Behavioral: Telehealth-Based Health and Wellness Program (POWERS-TBI)
The treatment program is interactive and will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse.

Outcome Measures

Primary Outcome Measures

  1. Health Promoting Lifestyle Profile II [Up to 13 months]

    HPLP-II; Total scores and subscale scores are summed and divided by number of items on each scale respectively for an average, with higher scores indicating greater lifestyle behaviors

Secondary Outcome Measures

  1. Barriers to Physical Activity and Disability Survey [Up to 13 months]

    BPADS: Response choices (yes/no) for 31 items are summarized; 3 items are open-ended, higher scores indicate greater barriers

  2. Social Support and Exercise Support for Eating and Physical Activity Habits [Up to 13 months]

    SSES: Subscale scores are obtained for exercise support (ranging from 10 for friends and 10 for family to 80 for friends and 80 for family); higher scores indicate greater support

  3. Stages of Change Readiness and Treatment Engagement Scale [Up to 13 months]

    SOCRATES: Items are summed and averaged across each subscale: Recognition scores range from 7-35; Ambivalence scores range from 4-20; Taking Steps scale range from 8-40: Higher scores indicate greater motivation

  4. Patient Health Questionnaire-9 Item [Up to 13 months]

    PHQ-9: Scores are summed and range from 0 to 27, higher scores indicate greater depressive symptomatology

  5. Fatigue Severity Scale [Up to 13 months]

    FSS: Scores range from 9 to 63 with higher scores indicating greater fatigue

  6. Bodily Pain Index [Up to 13 months]

    BPI: Scores for the Interference scale are summed and average for a mean (range 0 to 70) with higher scores indicating greater pain interference

  7. Craig Handicap Assessment Reporting Technique short form [Up to 13 months]

    CHARTsf: Suscales scores are summed and averaged for respective scales with higher scores indicating greater community integration

  8. Perceived Wellness Survey [Up to 13 months]

    PWS: A total score and subscale scores are calculated with a formula and range between 36 to 316 and average with higher scores indicating greater personal wellness

  9. Barriers to Health Activities among Disabled Persons scale [Up to 13 months]

    BHADP: Ratings are summed across each item for how interfering they are with health promotion (range of possible scores 18 to 72)

  10. Zarit Burden Scale [Up to 13 months]

    ZBS: Scores are summed (ranges 0 to 48) for a total scores, higher scores are indicative of greater burden

  11. Sociodemographic Characteristics [Up to 13 months]

    No abbreviation: Frequencies, summed total, or averages are reported to characterize the sample

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:
  • age 19 years or older

  • sustained a TBI

  • at least 6-months or greater out from injury

  • willing to work on one or more health goals among any of the following areas of focus (e.g., health knowledge, physical activity/exercise, dietary intake/nutrition, stress management, mental activity/stimulation, social ' relationships, leisure, sleep, mindfulness/spirituality, substance use)

  • able to potentially participate in physical activity or alter dietary intake, if that is a potential health goal (e.g., no medical contraindication given by their doctor)

  • not currently enrolled in a health and wellness program or research study involving a health/wellness program or intervention

  • indicates a potential health goal to lose weight and does not independently prepare their own meals, cook, grocery shop, but has a caregiver defined by providing some type of ongoing support (emotional or instrumental) who is willing to participate as a study partner during the intervention condition

  • has access to a telephone

  • has regular access to the internet from a computer or laptop

  • not pregnant (due to the effect on engaging in certain health promoting behaviors such as weight loss)

  • does not have a significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)

Exclusion criteria:
  • non-English speaking

  • difficulty hearing

  • significant problems with communication

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laura E. Dreer, PhD, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT04288258
Other Study ID Numbers:
  • 90DPTB0015
First Posted:
Feb 28, 2020
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022