NCT05403021

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

May 1, 2022

Last Update Submit

May 29, 2022

Conditions

Stroke

Keywords

caregiverinterventionpiloteducationgoalsskills

Outcome Measures

Primary Outcomes (4)

  • Perceived Stress Scale

    Scores range 0-40, higher score indicates higher perceived stress

    Baseline

  • Perceived Stress Scale

    Scores range 0-40, higher score indicates higher perceived stress

    Post-intervention (approximately 6 weeks)

  • Revised Scale for Caregiving Self-efficacy

    Scores range 0-100, higher score indicates higher self-efficacy

    Baseline

  • Revised Scale for Caregiving Self-efficacy

    Scores range 0-100, higher score indicates higher self-efficacy

    Post-intervention (approximately 6 weeks)

Secondary Outcomes (10)

  • Modified Caregiver Strain Index

    Baseline

  • Modified Caregiver Strain Index

    Post-intervention (approximately 6 weeks)

  • Patient-Reported Outcomes Measurement Information System-43 Profile v2.1

    Baseline

  • Patient-Reported Outcomes Measurement Information System-43 Profile v2.1

    Post-intervention (approximately 6 weeks)

  • Neuro-Quality of Life (Neuro-QOL) Positive Affect and Well-being v1.0

    Baseline

  • +5 more secondary outcomes

Other Outcomes (1)

  • Feedback survey

    Post-intervention (approximately 6 weeks)

Study Arms (1)

GETCare Intervention

EXPERIMENTAL
Behavioral: GETCare Intervention

Interventions

GETCare InterventionBEHAVIORAL

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.

GETCare Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related 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

    BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jackie Einerson, MOT

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: single-arm mixed method pilot trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2022

First Posted

June 2, 2022

Study Start

August 31, 2020

Primary Completion

August 17, 2021

Study Completion

August 20, 2021

Last Updated

June 2, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)