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

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: Telehealth-Based Health and Wellness Program (POWERS-TBI)

• Registration Number: NCT04288258
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Study Start: 2020-04-01
• Status Verified: 2023-10
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Telehealth-Based Health and Wellness Program (POWERS-TBI)	Health and Wellness Program

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Fatigue Severity Scale	Up to 13 months	FSS: Scores range from 9 to 63 with higher scores indicating greater fatigue
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
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
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
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
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
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)
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
Sociodemographic Characteristics	Up to 13 months	No abbreviation: Frequencies, summed total, or averages are reported to characterize the sample

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States