NCT06401655

Brief 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. 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

April 30, 2024

Last Update Submit

May 8, 2024

Conditions

Keywords

Financial capabilityFinancial managementFinancial self-efficacyGoal attainmentStrategy Training

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    through study completion, an average 3 months

Secondary Outcomes (3)

  • Financial Self Efficacy Scale (FSES) #1 - Rothwell

    through study completion, an average 3 months

  • Financial Self Efficacy Scale (FSES) #2 - Lown

    through study completion, an average 3 months

  • InCharge Financial Distress/Well-being Scale- Prawitz

    through study completion, an average 3 months

Other Outcomes (1)

  • Qualitative interviews

    through study completion, an average 3 months

Study Arms (1)

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).

Behavioral: Financial Coaching for People living with Acquired Brain Injury (FC-ABI)

Interventions

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).

Treatment group (pilot)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).
  • Close-Other Support Persons
  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Location

MeSH Terms

Conditions

Brain InjuriesStroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Lisa Engel, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 7, 2024

Study Start

February 21, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

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.

Locations