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

Traumatic Brain Injury Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04288258
• Other study ID #: 90DPTB0015
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fatigue Severity Scale	FSS: Scores range from 9 to 63 with higher scores indicating greater fatigue	Up to 13 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sociodemographic Characteristics	No abbreviation: Frequencies, summed total, or averages are reported to characterize the sample	Up to 13 months