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

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

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

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Telehealth-Based Health and Wellness Program (POWERS-TBI)

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Dreer, Ph.D.; Phone Number: (205) 325-8681; Email: lauradreer@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 13 months
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	Up to 13 months
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	Up to 13 months
Patient Health Questionnaire-9 Item	PHQ-9: Scores are summed and range from 0 to 27, higher scores indicate greater depressive symptomatology	Up to 13 months
Fatigue Severity Scale	FSS: Scores range from 9 to 63 with higher scores indicating greater fatigue	Up to 13 months
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	Up to 13 months
Craig Handicap Assessment Reporting Technique short form	CHARTsf: Suscales scores are summed and averaged for respective scales with higher scores indicating greater community integration	Up to 13 months
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	Up to 13 months
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)	Up to 13 months
Zarit Burden Scale	ZBS: Scores are summed (ranges 0 to 48) for a total scores, higher scores are indicative of greater burden	Up to 13 months
Sociodemographic Characteristics	No abbreviation: Frequencies, summed total, or averages are reported to characterize the sample	Up to 13 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 90DPTB0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will need IRB approval

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No