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Completed

NCT Number: NCT05403021

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GETCare Intervention

Behavioral

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.

Primary outcomes

  1. Perceived Stress Scale

    Time frame: Baseline

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

  2. Perceived Stress Scale

    Time frame: Post-intervention (approximately 6 weeks)

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

  3. Revised Scale for Caregiving Self-efficacy

    Time frame: Baseline

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

  4. Revised Scale for Caregiving Self-efficacy

    Time frame: Post-intervention (approximately 6 weeks)

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

Secondary outcomes

  1. Modified Caregiver Strain Index

    Time frame: Baseline

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

  2. Modified Caregiver Strain Index

    Time frame: Post-intervention (approximately 6 weeks)

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

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: Baseline

    9 items; Scores range 9-45, higher score indicates higher positive affect and well-being

  6. Neuro-Quality of Life (Neuro-QOL) Positive Affect and Well-being

    Time frame: Post-intervention (approximately 6 weeks)

    9 items; Scores range 9-45, higher score indicates higher positive affect and well-being

  7. Knowledge assessment

    Time frame: Baseline

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

  8. Knowledge assessment

    Time frame: Post-intervention (approximately 6 weeks)

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

  9. Canadian Occupational Performance Measure

    Time frame: 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

  10. Canadian Occupational Performance Measure

    Time frame: 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 outcomes

  1. Feedback survey

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Utah Occupational Therapy Association

Registry information

Acronym: GETCare

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2022
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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