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

Primary Purpose

Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth-Based Health and Wellness Program (POWERS-TBI)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Health and Wellness Program

Outcomes

Primary Outcome Measures

Health Promoting Lifestyle Profile II
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

Barriers to Physical Activity and Disability Survey
BPADS: Response choices (yes/no) for 31 items are summarized; 3 items are open-ended, higher scores indicate greater barriers
Social Support and Exercise Support for Eating and Physical Activity Habits
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
Stages of Change Readiness and Treatment Engagement Scale
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
Patient Health Questionnaire-9 Item
PHQ-9: Scores are summed and range from 0 to 27, higher scores indicate greater depressive symptomatology
Fatigue Severity Scale
FSS: Scores range from 9 to 63 with higher scores indicating greater fatigue
Bodily Pain Index
BPI: Scores for the Interference scale are summed and average for a mean (range 0 to 70) with higher scores indicating greater pain interference
Craig Handicap Assessment Reporting Technique short form
CHARTsf: Suscales scores are summed and averaged for respective scales with higher scores indicating greater community integration
Perceived Wellness Survey
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
Barriers to Health Activities among Disabled Persons scale
BHADP: Ratings are summed across each item for how interfering they are with health promotion (range of possible scores 18 to 72)
Zarit Burden Scale
ZBS: Scores are summed (ranges 0 to 48) for a total scores, higher scores are indicative of greater burden
Sociodemographic Characteristics
No abbreviation: Frequencies, summed total, or averages are reported to characterize the sample

Full Information

First Posted
February 21, 2020
Last Updated
October 25, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04288258
Brief Title
A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury
Acronym
POWERS-TBI
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
case-control crossover
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Health and Wellness Program
Intervention Type
Behavioral
Intervention Name(s)
Telehealth-Based Health and Wellness Program (POWERS-TBI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health Promoting Lifestyle Profile II
Description
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
Time Frame
Up to 13 months
Secondary Outcome Measure Information:
Title
Barriers to Physical Activity and Disability Survey
Description
BPADS: Response choices (yes/no) for 31 items are summarized; 3 items are open-ended, higher scores indicate greater barriers
Time Frame
Up to 13 months
Title
Social Support and Exercise Support for Eating and Physical Activity Habits
Description
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
Time Frame
Up to 13 months
Title
Stages of Change Readiness and Treatment Engagement Scale
Description
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
Time Frame
Up to 13 months
Title
Patient Health Questionnaire-9 Item
Description
PHQ-9: Scores are summed and range from 0 to 27, higher scores indicate greater depressive symptomatology
Time Frame
Up to 13 months
Title
Fatigue Severity Scale
Description
FSS: Scores range from 9 to 63 with higher scores indicating greater fatigue
Time Frame
Up to 13 months
Title
Bodily Pain Index
Description
BPI: Scores for the Interference scale are summed and average for a mean (range 0 to 70) with higher scores indicating greater pain interference
Time Frame
Up to 13 months
Title
Craig Handicap Assessment Reporting Technique short form
Description
CHARTsf: Suscales scores are summed and averaged for respective scales with higher scores indicating greater community integration
Time Frame
Up to 13 months
Title
Perceived Wellness Survey
Description
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
Time Frame
Up to 13 months
Title
Barriers to Health Activities among Disabled Persons scale
Description
BHADP: Ratings are summed across each item for how interfering they are with health promotion (range of possible scores 18 to 72)
Time Frame
Up to 13 months
Title
Zarit Burden Scale
Description
ZBS: Scores are summed (ranges 0 to 48) for a total scores, higher scores are indicative of greater burden
Time Frame
Up to 13 months
Title
Sociodemographic Characteristics
Description
No abbreviation: Frequencies, summed total, or averages are reported to characterize the sample
Time Frame
Up to 13 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Dreer, Ph.D.
Phone
(205) 325-8681
Email
lauradreer@uabmc.edu
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Dreer
Phone
205-325-8681
Email
lauradreer@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Laura Dreer, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Will need IRB approval

Learn more about this trial

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

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