Back to resultsMaximizing Energy After Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Maximizing Energy
Health Education
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, fatigue, self-management
Eligibility Criteria
Inclusion Criteria:
- Age: 18 years or older
- Patient lives within a 50 miles radius of the University of Pittsburgh in Oakland
- Diagnosis of TBI atleast 6 months ago: Individuals need time to determine if they have chronic fatigue after CA.
- Community dwelling: Community dwelling participants are more likely to be able to make environmental changes than those in institutions
- Vision to operate a computer:
- Presence of fatigue: Fatigue Severity Scale is a valid and reliable test used to measure the severity of fatigue on 9 fatigue-related statements on a 7 point ordinal scale. A score ≥ 4 signifies fatigue severe enough to limit daily activities.
- No cognitive impairment
- Functional English fluency and literacy
Exclusion Criteria:
- Physical impairment: Individuals scoring < 65 on the 13 Functional Independence Measure (FIM) motor items will be excluded from the study;
- Mood and mental health history: Individuals with a recent (less than 3 months) history of major depressive disorder, mania, hypomania, psychosis, or substance abuse as diagnosed by the PRIME-MD and the MiniInternational Neuropsychiatric Interview (MINI) unless treated or in partial remission will be excluded because their self-reports of participation in everyday life may not be reliable; and
- Disability due to other diagnoses: history of neurologic, traumatic, or psychiatric conditions.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Maximizing Energy
Health Education
Arm Description
The Maximizing Energy (MAX) intervention consists of two weekly 30-minute sessions delivered live via the Internet using web-camera technology for 8 weeks. The interventions are delivered by occupational therapists. The MAX intervention was developed by combining two active ingredients - Problem Solving Therapy and energy conservation strategy education. Participants engage in two introductory sessions during the first week of the intervention. During the first session in a week, participants practice the steps of MAX Intervention with a fatigue-related problem. At the end of the session, the participants identify a clearly defined action plan for solution implementation. Participants are asked to implement the solution over the next few days. The second session takes place later in the week. The interventionist reviews the problem, the identified solution, and its implementation. Participants use a workbook to support their application of the MAX Intervention.
consists of two weekly 30-minute sessions delivered live via the Internet using web-camera technology for 8 weeks. The interventionist delivered health education using a variety of health related topics relevant to individuals with TBI (e.g., characteristics and prevalence of fatigue after TBI, diet and nutrition, importance of exercise, energy conservation strategies).Participants use a workbook to follow along with the interventionist during the weekly sessions.
Outcomes
Primary Outcome Measures
Change in Fatigue Scores (Patient-Reported Outcomes Measurement Information System - Fatigue) Between Groups At 16 Weeks
The PROMIS Fatigue item banks assess a range of self-reported fatigue symptoms that likely decreases one's ability to execute daily activities and function normally in family or social roles. The computerized adaptive test version provides a mean fatigue score. The Scale uses a T-score metric in which 50 is the mean for the population and 10 is the standard deviation of that population. Higher scores equal more fatigue. Scores were obtained at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Secondary Outcome Measures
Change in Fatigue Impact Scores (Modified Fatigue Impact Scale) Between Groups At 16 Weeks
The Modified Fatigue Impact Scale is a self-report instrument that assesses the impact of fatigue on performance of everyday activities. The Scale has 21 items in three subscales: physical, cognitive, and psychosocial. A 5-point scale ranging from 0 (never) to 4 (almost always) is used for rating each item; items are summed to obtain a total score. Higher scores indicate greater impact of fatigue on performance of everyday activities. Total scores were obtained at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Change in Fatigue Severity Scores (Fatigue Severity Scale) Between Groups At 16 Weeks
The Modified Fatigue Severity Scale is a self-report instrument that assesses the severity of fatigue. The Scale has 9 items. A 7-point scale ranging from 1 (strong disagreement) to 7 (strong agreement) is used for rating each item; mean of the items yield a total score. Higher scores indicate greater fatigue severity. Total scores were obtained at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Change in Participation Scores (Participation Objective, Participation Subjective) Between Groups At 16 Weeks
Participation Objective, Participation Subjective (POPS) evaluates participation in everyday life in persons with TBI. The scale consists of 26 items sorted into five categories: Domestic life; Major life activities; Transportation; Interpersonal interactions and relationships; and Community, recreational and civic life. Scores on the objective questions are converted into standardized z scores ranging from -3 to +3. Higher scores indicate greater frequency of participation in everyday life. Scores on the subjective questions range from +4, indicating a "most important" area of life that the person is engaging in at a satisfactory level, to -4, indicating an equally important area of life that the person wants to do either less of or more of. Total scores were obtained at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Change in Physical Activity Between Groups At 16 Weeks
Physical activity data was collected with the Actical device. The Actical is a wireless, wearable body monitor that collects and analyzes raw physiological and lifestyle data. It was worn at the wrist for 3 days. Physical activity data was derived in terms of metabolic equivalents (METs) when participants engaged in physical activity. Total energy expenditure over 3 days were obtained at at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Change in Perceived Work Disability (Work Role Functioning Questionnaire) Between Groups At 16 Weeks
The Work Role Functioning Questionnaire (WRFQ) assesses the degree of perceived work disability due to a chronic health problem. The questionnaire consists of 27 items divided into five subscales: Work scheduling demands, Physical demands, Mental demands, Social demands, and Output demands. The participant scores each item on a 5 point ordinal scale (0 = difficult all the time, 4 = difficult none of the time). Each subscale is scored separately, by adding the response of each item, and converting the score from 0 (limited all the time) to 100 (never limited).
Full Information
NCT ID
NCT04238910
First Posted
January 15, 2020
Last Updated
April 24, 2023
Sponsor
University of Pittsburgh
Collaborators
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT04238910
Brief Title
Maximizing Energy After Traumatic Brain Injury
Official Title
Maximizing Energy After Traumatic Brain Injury: Feasibility and Effectiveness of Combined Problem Solving Therapy and Occupational Therapist Delivered Education
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2011 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
U.S. Army Medical Research and Development Command
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Traumatic brain injury (TBI) is the signature injury of the wars in Iraq and Afghanistan. Up to 73% of TBI patients endorse fatigue as their most challenging symptom.
Fatigue leads to decreased participation in everyday life and return to work. The Maximizing Energy (MAX) intervention trains individuals with TBI to manage their fatigue.
The intervention individualizes the Occupational Therapist delivered Energy Conservation Strategies education by using the framework of Problem Solving Therapy. The purpose of this single-blind randomized clinical trial was to test the effect of the Maximizing Energy (MAX) intervention for decreasing the impact and severity of post-TBI fatigue, increasing participation in everyday life and physical activity, and decreasing work disability.
Detailed Description
A significant proportion (50-80%) of individuals with traumatic brain injury (TBI) experience persistent fatigue and endorse it as the most distressing and challenging symptom that affects daily life. Chronic fatigue has a devastating impact on individuals because it leads to reduced participation in everyday life. Despite the high incidence of post-TBI fatigue and its impact on everyday life, these is a dearth of studies examining the effectiveness of non-pharmacological interventions for the treatment of post-TBI fatigue. This study is unique in that it will examine the effectiveness of a non-pharmacological intervention to manage post-TBI fatigue. The Maximizing Energy (MAX) Intervention, individuals with post-TBI fatigue will reduce the impact of fatigue on everyday life by actively seeking and implementing solutions for their fatigue-related problems, thus promoting their reintegration into the community.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Fatigue
Keywords
traumatic brain injury, fatigue, self-management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maximizing Energy
Arm Type
Experimental
Arm Description
The Maximizing Energy (MAX) intervention consists of two weekly 30-minute sessions delivered live via the Internet using web-camera technology for 8 weeks. The interventions are delivered by occupational therapists.
The MAX intervention was developed by combining two active ingredients - Problem Solving Therapy and energy conservation strategy education. Participants engage in two introductory sessions during the first week of the intervention. During the first session in a week, participants practice the steps of MAX Intervention with a fatigue-related problem. At the end of the session, the participants identify a clearly defined action plan for solution implementation. Participants are asked to implement the solution over the next few days. The second session takes place later in the week. The interventionist reviews the problem, the identified solution, and its implementation. Participants use a workbook to support their application of the MAX Intervention.
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
consists of two weekly 30-minute sessions delivered live via the Internet using web-camera technology for 8 weeks. The interventionist delivered health education using a variety of health related topics relevant to individuals with TBI (e.g., characteristics and prevalence of fatigue after TBI, diet and nutrition, importance of exercise, energy conservation strategies).Participants use a workbook to follow along with the interventionist during the weekly sessions.
Intervention Type
Behavioral
Intervention Name(s)
Maximizing Energy
Intervention Description
The intent of the MAX intervention is to personalize OT delivered education to facilitate the implementation of Energy Conservation strategies using the PST framework to address specific fatigue-related problems and then to generalize from these solutions to both similar and new situations in daily life.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
The intent of the health education intervention is to control for the non-specific effects of interactions with an interventionist. Participants received education on a variety of health related topics relevant to individuals with TBI.
Primary Outcome Measure Information:
Title
Change in Fatigue Scores (Patient-Reported Outcomes Measurement Information System - Fatigue) Between Groups At 16 Weeks
Description
The PROMIS Fatigue item banks assess a range of self-reported fatigue symptoms that likely decreases one's ability to execute daily activities and function normally in family or social roles. The computerized adaptive test version provides a mean fatigue score. The Scale uses a T-score metric in which 50 is the mean for the population and 10 is the standard deviation of that population. Higher scores equal more fatigue. Scores were obtained at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Time Frame
Baseline, Week 16
Secondary Outcome Measure Information:
Title
Change in Fatigue Impact Scores (Modified Fatigue Impact Scale) Between Groups At 16 Weeks
Description
The Modified Fatigue Impact Scale is a self-report instrument that assesses the impact of fatigue on performance of everyday activities. The Scale has 21 items in three subscales: physical, cognitive, and psychosocial. A 5-point scale ranging from 0 (never) to 4 (almost always) is used for rating each item; items are summed to obtain a total score. Higher scores indicate greater impact of fatigue on performance of everyday activities. Total scores were obtained at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Time Frame
Baseline, Week 16
Title
Change in Fatigue Severity Scores (Fatigue Severity Scale) Between Groups At 16 Weeks
Description
The Modified Fatigue Severity Scale is a self-report instrument that assesses the severity of fatigue. The Scale has 9 items. A 7-point scale ranging from 1 (strong disagreement) to 7 (strong agreement) is used for rating each item; mean of the items yield a total score. Higher scores indicate greater fatigue severity. Total scores were obtained at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Time Frame
Baseline, Week 16
Title
Change in Participation Scores (Participation Objective, Participation Subjective) Between Groups At 16 Weeks
Description
Participation Objective, Participation Subjective (POPS) evaluates participation in everyday life in persons with TBI. The scale consists of 26 items sorted into five categories: Domestic life; Major life activities; Transportation; Interpersonal interactions and relationships; and Community, recreational and civic life. Scores on the objective questions are converted into standardized z scores ranging from -3 to +3. Higher scores indicate greater frequency of participation in everyday life. Scores on the subjective questions range from +4, indicating a "most important" area of life that the person is engaging in at a satisfactory level, to -4, indicating an equally important area of life that the person wants to do either less of or more of. Total scores were obtained at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Time Frame
Baseline, Week 16
Title
Change in Physical Activity Between Groups At 16 Weeks
Description
Physical activity data was collected with the Actical device. The Actical is a wireless, wearable body monitor that collects and analyzes raw physiological and lifestyle data. It was worn at the wrist for 3 days. Physical activity data was derived in terms of metabolic equivalents (METs) when participants engaged in physical activity. Total energy expenditure over 3 days were obtained at at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Time Frame
Baseline, Week 16
Title
Change in Perceived Work Disability (Work Role Functioning Questionnaire) Between Groups At 16 Weeks
Description
The Work Role Functioning Questionnaire (WRFQ) assesses the degree of perceived work disability due to a chronic health problem. The questionnaire consists of 27 items divided into five subscales: Work scheduling demands, Physical demands, Mental demands, Social demands, and Output demands. The participant scores each item on a 5 point ordinal scale (0 = difficult all the time, 4 = difficult none of the time). Each subscale is scored separately, by adding the response of each item, and converting the score from 0 (limited all the time) to 100 (never limited).
Time Frame
Baseline, Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18 years or older
Patient lives within a 50 miles radius of the University of Pittsburgh in Oakland
Diagnosis of TBI atleast 6 months ago: Individuals need time to determine if they have chronic fatigue after CA.
Community dwelling: Community dwelling participants are more likely to be able to make environmental changes than those in institutions
Vision to operate a computer:
Presence of fatigue: Fatigue Severity Scale is a valid and reliable test used to measure the severity of fatigue on 9 fatigue-related statements on a 7 point ordinal scale. A score ≥ 4 signifies fatigue severe enough to limit daily activities.
No cognitive impairment
Functional English fluency and literacy
Exclusion Criteria:
Physical impairment: Individuals scoring < 65 on the 13 Functional Independence Measure (FIM) motor items will be excluded from the study;
Mood and mental health history: Individuals with a recent (less than 3 months) history of major depressive disorder, mania, hypomania, psychosis, or substance abuse as diagnosed by the PRIME-MD and the MiniInternational Neuropsychiatric Interview (MINI) unless treated or in partial remission will be excluded because their self-reports of participation in everyday life may not be reliable; and
Disability due to other diagnoses: history of neurologic, traumatic, or psychiatric conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ketki Raina, PhD, OTR/L
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26580691
Citation
Raina KD, Morse JQ, Chisholm D, Leibold ML, Shen J, Whyte E. Feasibility of a Cognitive Behavioral Intervention to Manage Fatigue in Individuals With Traumatic Brain Injury: A Pilot Study. J Head Trauma Rehabil. 2016 Sep-Oct;31(5):E41-9. doi: 10.1097/HTR.0000000000000196.
Results Reference
background
Learn more about this trial
Maximizing Energy After Traumatic Brain Injury
We'll reach out to this number within 24 hrs