Piloting GETCare: A Remote Goal-based Education and Skills Training Program for Caregivers Poststroke

Sponsor

University of Utah (Other)

Overall Status

Completed

CT.gov ID

NCT05403021

Collaborator

Utah Occupational Therapy Association (Other)

Enrollment

Location

Arm

11.6

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the GETCare program, a Goal-based Education and skills Training program for Caregivers poststroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: GETCare Intervention	N/A

Detailed Description

The purpose of this study was to utilize a single-arm mixed method pilot trial to evaluate the5-week GETCare program with the following study aims: (1) explore feasibility and acceptability, (2) assess knowledge acquisition and goal attainment, and (3) test preliminary effects on key caregiver outcomes. This remote program included guided goal setting, individualized resource recommendations, and education modules.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

single-arm mixed method pilot trialsingle-arm mixed method pilot trial

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Piloting GETCare: A Remote Goal-based Education and Skills Training Program for Caregivers Poststroke

Actual Study Start Date :

Aug 31, 2020

Actual Primary Completion Date :

Aug 17, 2021

Actual Study Completion Date :

Aug 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GETCare Intervention	Behavioral: GETCare Intervention This 5-week intervention was administered remotely and individually to caregivers utilizing phone, email, and a secure online platform. The GETCare program was mostly self-led and included five weekly module education topics: basics of stroke, caregiver skills, caregiver changes, meaningful participation, and community resources. Each module incorporated (1) individualized education, (2) goal setting, (3) skills training, and (4) community resource recommendations. The program was led by a licensed occupational therapist who is a certified stroke rehabilitation specialist. The occupational therapist conducted weekly check-ins via email or phone focused on answering questions, tracking goal progress, and assisting in problem solving.

Arm

Intervention/Treatment

Experimental: GETCare Intervention

Behavioral: GETCare Intervention

This 5-week intervention was administered remotely and individually to caregivers utilizing phone, email, and a secure online platform. The GETCare program was mostly self-led and included five weekly module education topics: basics of stroke, caregiver skills, caregiver changes, meaningful participation, and community resources. Each module incorporated (1) individualized education, (2) goal setting, (3) skills training, and (4) community resource recommendations. The program was led by a licensed occupational therapist who is a certified stroke rehabilitation specialist. The occupational therapist conducted weekly check-ins via email or phone focused on answering questions, tracking goal progress, and assisting in problem solving.

Outcome Measures

Primary Outcome Measures

Perceived Stress Scale [Baseline]
Scores range 0-40, higher score indicates higher perceived stress
Perceived Stress Scale [Post-intervention (approximately 6 weeks)]
Scores range 0-40, higher score indicates higher perceived stress
Revised Scale for Caregiving Self-efficacy [Baseline]
Scores range 0-100, higher score indicates higher self-efficacy
Revised Scale for Caregiving Self-efficacy [Post-intervention (approximately 6 weeks)]
Scores range 0-100, higher score indicates higher self-efficacy

Secondary Outcome Measures

Modified Caregiver Strain Index [Baseline]
Scores range 0-26, higher score indicates higher caregiver strain
Modified Caregiver Strain Index [Post-intervention (approximately 6 weeks)]
Scores range 0-26, higher score indicates higher caregiver strain
Patient-Reported Outcomes Measurement Information System-43 Profile v2.1 [Baseline]
43 items across seven domains: physical function, anxiety, fatigue, depression, sleep disturbance, ability to participate in social roles and activities, and pain interference; Scores range 6-30 for each subscale. For subscales of anxiety, depression, fatigue, and sleep disturbance, higher scores indicate worse symptoms. For subscale of social participation, higher scores indicate improved symptoms. Subscales of physical function and pain interference were not included in analyses, since they were not expected to change through this intervention.
Patient-Reported Outcomes Measurement Information System-43 Profile v2.1 [Post-intervention (approximately 6 weeks)]
43 items across seven domains: physical function, anxiety, fatigue, depression, sleep disturbance, ability to participate in social roles and activities, and pain interference; Scores range 6-30 for each subscale. For subscales of anxiety, depression, fatigue, and sleep disturbance, higher scores indicate worse symptoms. For subscale of social participation, higher scores indicate improved symptoms. Subscales of physical function and pain interference were not included in analyses, since they were not expected to change through this intervention.
Neuro-Quality of Life (Neuro-QOL) Positive Affect and Well-being v1.0 [Baseline]
9 items; Scores range 9-45, higher score indicates higher positive affect and well-being
Neuro-Quality of Life (Neuro-QOL) Positive Affect and Well-being [Post-intervention (approximately 6 weeks)]
9 items; Scores range 9-45, higher score indicates higher positive affect and well-being
Knowledge assessment [Baseline]
Evaluate knowledge acquisition of weekly education topics; Scores range 0-35, higher score indicates higher knowledge
Knowledge assessment [Post-intervention (approximately 6 weeks)]
Evaluate knowledge acquisition of weekly education topics; Scores range 0-35, higher score indicates higher knowledge
Canadian Occupational Performance Measure [Baseline]
Assesses importance of goal, current performance of goal, and satisfaction with current performance of goal; Scores range 0-10, higher score indicates higher importance, performance, and satisfaction with performance
Canadian Occupational Performance Measure [Post-intervention (approximately 6 weeks)]
Assesses importance of goal, current performance of goal, and satisfaction with current performance of goal; Scores range 0-10, higher score indicates higher importance, performance, and satisfaction with performance

Other Outcome Measures

Feedback survey [Post-intervention (approximately 6 weeks)]
Included a variety of questions (no/yes, Likert scales, and open-ended questions) regarding feedback of the intervention. For example, "Please indicate how helpful the additional handouts and videos were for you" (0 = not at all helpful, 1 = a little helpful, 2 = somewhat helpful, 3 = quite helpful, 4 = extremely helpful).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

self-identification as a primary caregiver (direct care involvement) of someone who had a stroke (no restriction on stroke duration)
≥ 18 years old
access to internet/telephone throughout the study
able to speak, read, and understand English
person with stroke expected to discharge within 1 month if still in the hospital