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

Stroke Clinical Trial

— GETCare  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05403021
• Other study ID #: 00129713
• Secondary ID: 00112906
• Status: Completed
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: May 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 20, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• unable to read and follow basic instructions
• indicated the individual with stroke had no deficits poststroke

Related Conditions & MeSH terms

• Stroke

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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Utah Occupational Therapy Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

Einerson, J., & Terrill, A. (2019). GETCare: Development of a Comprehensive Education and Training Program For Care-Partners Post-Stroke. Archives of Physical Medicine and Rehabilitation, 100(10), e8. https://doi.org/https://doi.org/10.1016/j.apmr.2019.08.012

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feedback survey	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).	Post-intervention (approximately 6 weeks)
Primary	Perceived Stress Scale	Scores range 0-40, higher score indicates higher perceived stress	Baseline
Primary	Perceived Stress Scale	Scores range 0-40, higher score indicates higher perceived stress	Post-intervention (approximately 6 weeks)
Primary	Revised Scale for Caregiving Self-efficacy	Scores range 0-100, higher score indicates higher self-efficacy	Baseline
Primary	Revised Scale for Caregiving Self-efficacy	Scores range 0-100, higher score indicates higher self-efficacy	Post-intervention (approximately 6 weeks)
Secondary	Modified Caregiver Strain Index	Scores range 0-26, higher score indicates higher caregiver strain	Baseline
Secondary	Modified Caregiver Strain Index	Scores range 0-26, higher score indicates higher caregiver strain	Post-intervention (approximately 6 weeks)
Secondary	Patient-Reported Outcomes Measurement Information System-43 Profile v2.1	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.	Baseline
Secondary	Patient-Reported Outcomes Measurement Information System-43 Profile v2.1	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.	Post-intervention (approximately 6 weeks)
Secondary	Neuro-Quality of Life (Neuro-QOL) Positive Affect and Well-being v1.0	9 items; Scores range 9-45, higher score indicates higher positive affect and well-being	Baseline
Secondary	Neuro-Quality of Life (Neuro-QOL) Positive Affect and Well-being	9 items; Scores range 9-45, higher score indicates higher positive affect and well-being	Post-intervention (approximately 6 weeks)
Secondary	Knowledge assessment	Evaluate knowledge acquisition of weekly education topics; Scores range 0-35, higher score indicates higher knowledge	Baseline
Secondary	Knowledge assessment	Evaluate knowledge acquisition of weekly education topics; Scores range 0-35, higher score indicates higher knowledge	Post-intervention (approximately 6 weeks)
Secondary	Canadian Occupational Performance Measure	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	Baseline
Secondary	Canadian Occupational Performance Measure	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	Post-intervention (approximately 6 weeks)