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StrokeGETCareNCT05403021

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

A study testing GETCare Intervention in people with Stroke, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
GETCare Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
31 Aug 2020to 20 Aug 2021
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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

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

Read the 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.

Conditions
Stroke
Being tested
GETCare Intervention
Keywords
caregiver, intervention, pilot, education, goals, skills
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GETCare InterventionBehavioural

    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.

Study groups in NCT05403021
Study groupRoleWhat they receive
GETCare InterventionExperimentalNot described
Receives: Behavioral: GETCare Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Stress Scale

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

    Measured: Baseline

  2. Perceived Stress Scale

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

    Measured: Post-intervention (approximately 6 weeks)

  3. Revised Scale for Caregiving Self-efficacy

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

    Measured: Baseline

  4. Revised Scale for Caregiving Self-efficacy

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

    Measured: Post-intervention (approximately 6 weeks)

Secondary outcomes (10)

  1. Modified Caregiver Strain Index

    Scores range 0-26, higher score indicates higher caregiver strain

    Measured: Baseline

  2. Modified Caregiver Strain Index

    Scores range 0-26, higher score indicates higher caregiver strain

    Measured: Post-intervention (approximately 6 weeks)

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Post-intervention (approximately 6 weeks)

  5. 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

    Measured: Baseline

  6. 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

    Measured: Post-intervention (approximately 6 weeks)

  7. Knowledge assessment

    Evaluate knowledge acquisition of weekly education topics; Scores range 0-35, higher score indicates higher knowledge

    Measured: Baseline

  8. Knowledge assessment

    Evaluate knowledge acquisition of weekly education topics; Scores range 0-35, higher score indicates higher knowledge

    Measured: Post-intervention (approximately 6 weeks)

  9. 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

    Measured: Baseline

  10. 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

    Measured: Post-intervention (approximately 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start31 Aug 2020
  3. Primary completion17 Aug 2021
  4. Study completion20 Aug 2021

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
single-arm mixed method pilot trial
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05403021
Sponsor's protocol ID
00129713
Other IDs
00112906
Acronym
GETCare
Status last verified
May 2022
First submitted
1 May 2022
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing GETCare Intervention in people with Stroke, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 2 Jun 2022. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Perceived Stress Scale (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05403021, which also lists 1 linked publication.

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 2 Jun 2022.

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