Brain InjuriesNCT06401655
Financial Coaching for Adults Living With Acquired Brain Injury
A study testing Financial Coaching for People living with Acquired Brain Injury (FC-ABI) in people with Brain Injuries and Stroke, run by University of Manitoba at 1 site in Canada.
Trial summary
This pilot study will utilize a longitudinal concurrent mixed-methods research design that gathers and analyzes qualitative and quantitative data overtime about a new 10-session financial coaching program the investigators have developed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Stroke
- What is being tested?
- Financial Coaching for People living with Acquired Brain Injury (FC-ABI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 21 Feb 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Acquired Brain Injury (ABI-Survivor) Participants
The inclusion criteria for ABI-survivor participants are:
- Age 18 years or older
- Self-report living with ABI (e.g., traumatic brain injury, stroke, non-traumatic brain injury, or brain injury due to other mechanisms) and chronic/ongoing ABI related symptoms or changes.
- Self-report to be at least 6 months since the last or only ABI incident (to ensure not in acute stage of brain injury recovery).
- Currently living in Winnipeg, Manitoba (i.e., the city where the in-person intervention sessions will take place).
- Can participate sessions that are up to 1-hour in length.
- Can identify 3 financial-related goals they want to address during the study/financial coaching program over the next 3-4 months.
- Are interested in wanting to address their financial-related goals with a trained Occupational Therapist.
- Able to attend in-person sessions at various Winnipeg locations that are convenient for them and if transportation cost support is provided (e.g., parking costs, bus tickets, taxi costs).
The exclusion criteria for ABI-survivor participants are:
- Are not able to participate in in-person sessions that are at least 45 minutes long.
- Are not able to communicate in English (verbal \& written)
- Unable to complete informed consent and capacity check questions for this study (see informed consent forms).
As the investigators are only looking to recruit up to five (n=5) ABI-survivor participants for this study, during screening the investigators will use maximum variation sampling (a specific form of purposive sampling) to guide inclusion if more than five ABI-survivors express interest in this study and are eligible to participate. During screening, the investigators will ask people about self-identified gender in an open-ended question that the investigators then categorize (i.e., man, woman, non-binary) and age (i.e., 18-30 years old, 31-60 years old, greater than 60 years old). Age and gender have been noted to have an influence on financial capability and financial well-being.
Close-Other Support Persons
The inclusion criteria for the Close-Other Support Person are:
- Be identified by the ABI-survivor participant as someone they would like to have involved in this intervention.
- Be 18 years or older.
- Live in Winnipeg, Manitoba or immediate surrounding environment.
- Be willing and able to participate in at least 3 sessions in-person financial coaching intervention sessions with the ABI-survivor participant (with times and locations to be scheduled convenient to support-person, the ABI-survivor participant, and OT interventionist)
The exclusion criteria for the Close-Other Support Person are:
- Are not able to participate in in-person sessions that are at least 45 minutes long.
- Are not able to communicate in English (verbal \& written)
- Unable to complete informed consent and capacity check questions for this study (see informed consent forms).
- The ABI-participant does not provide consent for this person to be a part of their intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study About Financial Coaching for Adults Living With Acquired Brain Injury
This pilot study will utilize a longitudinal concurrent mixed-methods research design that gathers and analyzes qualitative and quantitative data overtime about a new 10-session financial coaching program the investigators have developed. The data collected will be used to inform improvements to future related studies and programs for people living with acquired brain injury (ABI).
These mixed-methods data from each method will be integrated to provide a comprehensive understanding of the intervention (i.e., the financial coaching program). Each individualized intervention per ABI-survivor participant will be completed over 3-4 months (i.e., 12-14 weeks).
Read the detailed description
The people to be recruited in the study include:
- Adults living with acquired brain injuries (ABI; "ABI-survivor participant"), and
- Close or trusted others of the adult participants who live with ABI (involvement with the consent of the adult living with ABI; "Close-other support person").
The investigators will recruit participants through community partner organizations. The principal investigator (Dr. Engel) has established relationship with community organizations.
The primary participants for this study are adults who live with Acquired Brain Injury (ABI; i.e., ABI-survivor participants). However, with the consent and guidance of the ABI-survivor participants, the investigators will invite up to one close-other (e.g., caregiver, family, involved friend) of the ABI-survivor participant to take part in the study as a support-person in the intervention with the ABI-survivor participant (involvement of close-others is described more below).
The investigators will recruit up to five ABI-survivors (n=5), each who may or may not have a support person involved in the study. This sample size will be sufficient to generate required information for the study aim and objectives, as there will be some homogeneity to the sample (i.e., adults living with ABI) while also looking for heterogeneity in other participant qualities (i.e., gender, age, time since first brain injury).
The total time in this study for an ABI-survivor participant is 10 hours and 15 minutes which includes 7.5 hours of intervention time and 2.75 hours of data collection time.
This is an individualized, in-person 10-session financial coaching intervention program. Each session is 45-minutes. In total, participants will be asked to participate in up to 7 hours and 30 minutes of intervention time with a trained Occupational Therapist. Each session will happen 1-1.5 weeks apart and the financial coaching program will last over 3-4 months.
The Financial Coaching Program (FCp) will consist of 10 sessions that will last 45-minutes per session. Each session will be in a 1:1 format with the participant and financial coach (i.e., interventionist) who is a trained and registered Occupational Therapist. Participants are welcome to invite a close other (e.g., family, caregiver, friend) to attend and participate in sessions as a support person and as agreed upon during informed consent and while getting started in the study; although, at any time the participant can choose to not include or stop including their close other for some or all of the remaining FCp sessions.
FCp sessions will take place in a variety of spaces, dependent on the participant's preference. Sessions can be completed in the participant's home, the meeting spaces of the Manitoba Brain Injury Association, or office space in the College of Rehabilitation Science building. Sessions can take place in another community space if requested by the participant.
The FCp will follow a Cognitive Orientation to daily Occupational Performance (CO-OP) format. The CO-OP method will focus on building skills through the development and use of cognitive strategies. These problem-solving strategies can then be used to improve performance in other aspects of daily life and in new situations. The FCp financial coaches have been trained in CO-OP basics online course and completed the certificate consolidation course.
During the FCp sessions, the participant will work with a financial coach to practice problem solving skills and work toward achieving 3 financial goals: 2 of these goals will be addressed directly during multiple FCp sessions and 1 goal will be "unaddressed" or "untrained", only to be discussed in the last session related to generalization of learning to other goals. The financial coach will not instruct participants but will instead work collaboratively with them to develop strategies and action plans. The participant and financial coach will agree on homework assignments to complete between sessions, which will be reviewed at the beginning of each subsequent session.
The FCp will be facilitated by a financial coach (I.e, intervnetionists), who will be a paid research staff member and part of the research team identified in the informed consent forms. The financial coach is an occupational therapist with experience working with individuals with brain injury. The financial coaches hired for this study have completed the following additional training:
- Cognitive Orientation to Occupational Performance (CO-OP) comprehensive online course and completed the certificate consolidation
- SEED Financial Empowerment Program certificate training for financial literacy/capability facilitators (train-the-trainer program; https://seedwinnipeg.ca)
- Training through Prosper Canada Financial Empowerment Foundations
- Conditions
- Brain Injuries, Stroke
- Being tested
- Financial Coaching for People living with Acquired Brain Injury (FC-ABI)
- Keywords
- Financial capability, Financial management, Financial self-efficacy, Goal attainment, Strategy Training
- Medical subject headings
- Brain Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial Coaching for People living with Acquired Brain Injury (FC-ABI)Behavioural
This is an individualized, in-person 10-session financial coaching intervention program. Each session is 45-minutes. In total, participants will be asked to participate in up to 7 hours and 30 minutes of intervention time with a trained Occupational Therapist. Each session will happen 1-1.5 weeks apart and the financial coaching program will last over 3-4 months. The financial coaching sessions will only be offered in-person (at MBIA Winnipeg location, in their home, at the University of Manitoba/Banntyne Campus, or other community locations acceptable/consented by the participant).
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (pilot) | Experimental | The total time in this study for an ABI-survivor participant is 10 hours and 15 minutes which includes 7.5 hours of intervention time and 2.75 hours of data collection time.
This is an individualized, in-person 10-session financial coaching intervention program. Each session is 45-minutes. In total, participants will be asked to participate in up to 7 hours and 30 minutes of intervention time with a trained Occupational Therapist. Each session will happen 1-1.5 weeks apart and the financial coaching program will last over 3-4 months. The financial coaching sessions will only be offered in-person (at MBIA Winnipeg location, in their home, at the University of Manitoba/Banntyne Campus, or other community locations acceptable/consented by the participant). Receives: Behavioral: Financial Coaching for People living with Acquired Brain Injury (FC-ABI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
COPM is a client-centred tool for individuals to identify and rank problems that restrict their participant in their daily life. Scale score 0-10 on satisfaction and 0-10 on performance of two study goals. Higher scores means more satisfaction or more self-perceived performance related to the goal.
Measured: through study completion, an average 3 months
Goal Attainment Scaling (GAS)
Goal attainment scaling is a client-centred approach that makes it easier for clients to create personalized and relevant goals for therapy and tracks how far the intervention is moving in the direction of attaining the set goals. Scale of 1-5 for each goals, where 3 is equal to goal being met, 1-2 is goal progress but goal not met, and 4-5 is goal is met and exceeded.
Measured: through study completion, an average 3 months
Secondary outcomes (3)
Financial Self Efficacy Scale (FSES) #1 - Rothwell
FSES is a measure of an individual's skills, knowledge and ability to manage their household finance. Scale responses 4-20, with higher numbers indicating more financial self-efficacy.
Measured: through study completion, an average 3 months
Financial Self Efficacy Scale (FSES) #2 - Lown
FSES was developed as a tool for researchers to measure how behavior financial management and a basis for understanding, motivating, and guiding clients. Scale 4-24, with higher scores indicating more financial self-efficacy.
Measured: through study completion, an average 3 months
InCharge Financial Distress/Well-being Scale- Prawitz
The InCharge financial distress/financial well-being scale measure a latent construct representing one's financial state on a continuum ranging from distress or lowest level of financial well-being to no distress/highest level of financial well-being. Scale 8-80, with higher scores indicating less financial distress/more financial wellbeing.
Measured: through study completion, an average 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start21 Feb 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This pilot study will utilize a longitudinal concurrent mixed-methods research design that gathers and analyzes qualitative and quantitative data overtime about a new 10-session financial coaching program the investigators have developed. The data collected will be used to inform improvements to future related studies and programs for people living with brain injury.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Engel, University of Manitoba
- Investigators
- Lisa Engel, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401655
- Sponsor's protocol ID
- HS26252 (H2023:356)
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for sharing individual participant data to other researchers as dataset includes full qualitative interview transcripts which could identify participants if shared in entirety.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study About Financial Coaching for Adults Living With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT06401655
- Acronym / sponsor ID
- HS26252 (H2023:356)
- Conditions
- Brain Injuries, Stroke
- Keywords
- Financial capability, Financial management, Financial self-efficacy, Goal attainment, Strategy Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will utilize a longitudinal concurrent mixed-methods research design that gathers and analyzes qualitative and quantitative data overtime about a new 10-session financial coaching program the investigators have developed. The data collected will be used to inform improvements to future related studies and programs for people living with acquired brain injury (ABI).
These mixed-methods data from each method will be integrated to provide a comprehensive understanding of the intervention (i.e., the financial coaching program). Each individualized intervention per ABI-survivor participant will be completed over 3-4 months (i.e., 12-14 weeks).
Detailed description
The people to be recruited in the study include:
- Adults living with acquired brain injuries (ABI; "ABI-survivor participant"), and
- Close or trusted others of the adult participants who live with ABI (involvement with the consent of the adult living with ABI; "Close-other support person").
The investigators will recruit participants through community partner organizations. The principal investigator (Dr. Engel) has established relationship with community organizations.
The primary participants for this study are adults who live with Acquired Brain Injury (ABI; i.e., ABI-survivor participants). However, with the consent and guidance of the ABI-survivor participants, the investigators will invite up to one close-other (e.g., caregiver, family, involved friend) of the ABI-survivor participant to take part in the study as a support-person in the intervention with the ABI-survivor participant (involvement of close-others is described more below).
The investigators will recruit up to five ABI-survivors (n=5), each who may or may not have a support person involved in the study. This sample size will be sufficient to generate required information for the study aim and objectives, as there will be some homogeneity to the sample (i.e., adults living with ABI) while also looking for heterogeneity in other participant qualities (i.e., gender, age, time since first brain injury).
The total time in this study for an ABI-survivor participant is 10 hours and 15 minutes which includes 7.5 hours of intervention time and 2.75 hours of data collection time.
This is an individualized, in-person 10-session financial coaching intervention program. Each session is 45-minutes. In total, participants will be asked to participate in up to 7 hours and 30 minutes of intervention time with a trained Occupational Therapist. Each session will happen 1-1.5 weeks apart and the financial coaching program will last over 3-4 months.
The Financial Coaching Program (FCp) will consist of 10 sessions that will last 45-minutes per session. Each session will be in a 1:1 format with the participant and financial coach (i.e., interventionist) who is a trained and registered Occupational Therapist. Participants are welcome to invite a close other (e.g., family, caregiver, friend) to attend and participate in sessions as a support person and as agreed upon during informed consent and while getting started in the study; although, at any time the participant can choose to not include or stop including their close other for some or all of the remaining FCp sessions.
FCp sessions will take place in a variety of spaces, dependent on the participant's preference. Sessions can be completed in the participant's home, the meeting spaces of the Manitoba Brain Injury Association, or office space in the College of Rehabilitation Science building. Sessions can take place in another community space if requested by the participant.
The FCp will follow a Cognitive Orientation to daily Occupational Performance (CO-OP) format. The CO-OP method will focus on building skills through the development and use of cognitive strategies. These problem-solving strategies can then be used to improve performance in other aspects of daily life and in new situations. The FCp financial coaches have been trained in CO-OP basics online course and completed the certificate consolidation course.
During the FCp sessions, the participant will work with a financial coach to practice problem solving skills and work toward achieving 3 financial goals: 2 of these goals will be addressed directly during multiple FCp sessions and 1 goal will be "unaddressed" or "untrained", only to be discussed in the last session related to generalization of learning to other goals. The financial coach will not instruct participants but will instead work collaboratively with them to develop strategies and action plans. The participant and financial coach will agree on homework assignments to complete between sessions, which will be reviewed at the beginning of each subsequent session.
The FCp will be facilitated by a financial coach (I.e, intervnetionists), who will be a paid research staff member and part of the research team identified in the informed consent forms. The financial coach is an occupational therapist with experience working with individuals with brain injury. The financial coaches hired for this study have completed the following additional training:
- Cognitive Orientation to Occupational Performance (CO-OP) comprehensive online course and completed the certificate consolidation
- SEED Financial Empowerment Program certificate training for financial literacy/capability facilitators (train-the-trainer program; https://seedwinnipeg.ca)
- Training through Prosper Canada Financial Empowerment Foundations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This pilot study will utilize a longitudinal concurrent mixed-methods research design that gathers and analyzes qualitative and quantitative data overtime about a new 10-session financial coaching program the investigators have developed. The data collected will be used to inform improvements to future related studies and programs for people living with brain injury.
| Arm | Type | Receives |
|---|---|---|
| Treatment group (pilot) | Experimental | Behavioral: Financial Coaching for People living with Acquired Brain Injury (FC-ABI)The total time in this study for an ABI-survivor participant is 10 hours and 15 minutes which includes 7.5 hours of intervention time and 2.75 hours of data collection time. This is an individualized, in-person 10-session financial coaching intervention program. Each session is 45-minutes. In total, participants will be asked to participate in up to 7 hours and 30 minutes of intervention time with a trained Occupational Therapist. Each session will happen 1-1.5 weeks apart and the financial coaching program will last over 3-4 months. The financial coaching sessions will only be offered in-person (at MBIA Winnipeg location, in their home, at the University of Manitoba/Banntyne Campus, or other community locations acceptable/consented by the participant). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial Coaching for People living with Acquired Brain Injury (FC-ABI)This is an individualized, in-person 10-session financial coaching intervention program. Each session is 45-minutes. In total, participants will be asked to participate in up to 7 hours and 30 minutes of intervention time with a trained Occupational Therapist. Each session will happen 1-1.5 weeks apart and the financial coaching program will last over 3-4 months. The financial coaching sessions will only be offered in-person (at MBIA Winnipeg location, in their home, at the University of Manitoba/Banntyne Campus, or other community locations acceptable/consented by the participant). | Behavioural | Treatment group (pilot) |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: through study completion, an average 3 months
COPM is a client-centred tool for individuals to identify and rank problems that restrict their participant in their daily life. Scale score 0-10 on satisfaction and 0-10 on performance of two study goals. Higher scores means more satisfaction or more self-perceived performance related to the goal.
Goal Attainment Scaling (GAS)
Time frame: through study completion, an average 3 months
Goal attainment scaling is a client-centred approach that makes it easier for clients to create personalized and relevant goals for therapy and tracks how far the intervention is moving in the direction of attaining the set goals. Scale of 1-5 for each goals, where 3 is equal to goal being met, 1-2 is goal progress but goal not met, and 4-5 is goal is met and exceeded.
3 secondary outcomes
Financial Self Efficacy Scale (FSES) #1 - Rothwell
Time frame: through study completion, an average 3 months
Financial Self Efficacy Scale (FSES) #2 - Lown
Time frame: through study completion, an average 3 months
InCharge Financial Distress/Well-being Scale- Prawitz
Time frame: through study completion, an average 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No. No plan for sharing individual participant data to other researchers as dataset includes full qualitative interview transcripts which could identify participants if shared in entirety.
Related trials for Brain Injuries
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Engel, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Coaching for People living with Acquired Brain Injury (FC-ABI) in people with Brain Injuries and Stroke, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: through study completion, an average 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.