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Completed

NCT Number: NCT04288258

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

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

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth-Based Health and Wellness Program (POWERS-TBI)

Behavioral

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 outcomes

  1. Health Promoting Lifestyle Profile II

    Time frame: 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 outcomes

  1. Barriers to Physical Activity and Disability Survey

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 13 months

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

  6. Bodily Pain Index

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 13 months

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study 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

Acronym: POWERS-TBI

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2020
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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