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Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke (CARE-CITE R21)

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ClinicalTrials.gov Identifier: NCT04040751
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Sarah Blanton, Emory University

Brief Summary:
A novel, web-based carepartner focused intervention (CARE-CITE) is designed to foster problem solving and skill building while facilitating carepartner engagement during upper extremity functional activities in the home setting. The proposed study will evaluate the application of the CARE-CITE intervention paired with usual and customary care during the sub-acute stroke.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: CARE-CITE Behavioral: Standard of care Not Applicable

Detailed Description:

Stroke is a leading cause of long-term disability and to date, research has placed little emphasis on how to integrate carepartners (family members) into the rehabilitation process without increasing negative carepartner outcomes.

A novel, web-based carepartner focused intervention (CARE-CITE) is designed to foster problem solving and skill building while facilitating carepartner engagement during upper extremity functional activities in the home setting. The proposed study will evaluate the application of the CARE-CITE intervention paired with usual and customary care during the sub-acute stroke.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: CARE-CITE Carepartner
This study arm consists of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8.
Behavioral: CARE-CITE
The primary CARE-CITE components will be education via web platform. CP completes 6 online CARE-CITE modules (15-30-minute sessions each). Modules include demonstration videos and instructive content covering following areas: principles of functional task practice (i.e., activities of daily living such as eating, grooming, or leisure/vocational activities), adaptation of tasks, and importance of progression of challenging tasks to drive neuroplasticity (i.e., increasing numbers of practice repetitions or weight of objects lifted). Underpinning the content is the concept of autonomy support, with examples of fostering empathy, problem solving, instruction in the use of non-controlling language with role playing situations and the importance of creating choice in activities.

Active Comparator: Control Carepartners
Carepartners (CP) receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The CP will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups.
Behavioral: Standard of care
The CP will receive a CP support brochure with general caregiving information including website resources to mimic web interaction of intervention group (e.g., stroke caregiver resource site).

Experimental: CARE-CITE Stroke Survivor
This study arm consists of stroke survivors of carepartners receiving the CARE-CITE intervention. The CARE-CITE intervention will occur over 4 weeks in the dyad's home. The research interventionist will conduct two in-home visits (at orientation and during week 4), two phone call visits (at weeks 2 and 3), and one telephone follow up at week 8.
Behavioral: CARE-CITE
The primary CARE-CITE components will be education via web platform. CP completes 6 online CARE-CITE modules (15-30-minute sessions each). Modules include demonstration videos and instructive content covering following areas: principles of functional task practice (i.e., activities of daily living such as eating, grooming, or leisure/vocational activities), adaptation of tasks, and importance of progression of challenging tasks to drive neuroplasticity (i.e., increasing numbers of practice repetitions or weight of objects lifted). Underpinning the content is the concept of autonomy support, with examples of fostering empathy, problem solving, instruction in the use of non-controlling language with role playing situations and the importance of creating choice in activities.

Active Comparator: Control Stroke Survivors
Stroke survivors (SS) or carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The CP will receive the same number of structured weekly phone calls and the "booster call" to answer any questions, assess helpfulness of the information and ascertain if there was any use of the web resources or social support groups.
Behavioral: Standard of care
The CP will receive a CP support brochure with general caregiving information including website resources to mimic web interaction of intervention group (e.g., stroke caregiver resource site).




Primary Outcome Measures :
  1. Change in Carepartner (CP) Depression using Center for Epidemiologic Studies - Depression (CES-D) Scale score [ Time Frame: Baseline and 2 months post-intervention ]
    CES-D is 20-item, Likert-type scale (range 0-none/rare to 3-most/all of the time). The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.

  2. Change in Carepartner (CP) quality of life using Short Form Health Survey (SF-36) Scale score [ Time Frame: Baseline and 2 months post-intervention ]
    SF-36 is a 36-item Likert-type scale,mental health domain. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  3. Change in SS Upper Extremity Function using Wolf Motor Function Test (WMFT) score [ Time Frame: Baseline and 2 months post-intervention ]
    The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks. The first 6 items involve timed functional tasks, items 7 and 14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The items are rated on a 6-point scale. Lower scores are indicative of lower functioning levels.

  4. Change in SS Upper Extremity Function using Motor Activity Log (MAL) score [ Time Frame: Baseline and 2 months post-intervention ]
    Motor Activity Log is 30-item questionnaire with Likert-type scale. The MAL adopts a 6-point ordinal scale, although patients can attribute a half-score, resulting in 11-point Likert scales with specified anchoring definitions at 6 points. High core represents high quality upper extremity use.

  5. Change in Stroke Survivor (SS) Quality of Life using Stroke Impact Scale (SIS) score [ Time Frame: Baseline and 2 months post-intervention ]
    Stroke Impact Scale (SIS) 59-items are broken down into eight domains: strength, hand function, mobility, activities of daily living, emotion, memory, communication, social participation. Domains are scored on a metric of 0 to 100, with higher scores indicating better self-reported health.


Secondary Outcome Measures :
  1. Change in Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score [ Time Frame: Baseline and 2 months post-intervention ]
    The Family Care Climate Questionnaire (FCCQ) for carepartners is 14-item questionnaire asking about the carepartners' experiences with the strokes survivor in relation to their rehabilitation activities. Each item is rated on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true). Item scores are averaged to provide an overall score between 1 and 7 where higher scores indicate the carepartner thinks they are providing high autonomy support to the stroke survivor.

  2. Change in Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score [ Time Frame: Baseline and 2 months post-intervention ]
    The Family Care Climate Questionnaire (FCCQ) for stroke survivors is 14-item questionnaire asking about experiences with family members in relation to rehabilitation activities. Each item is rated on a 7-point Likert scale ranging from 1 (not true at all) to 7 (very true). Item scores are averaged to provide an overall score between 1 and 7 where higher scores indicate the stroke survivor perceives receiving high autonomy support from the carepartner.

  3. Change in CP Family Conflict using Family Caregiver Conflict Scale (FCCS) score [ Time Frame: Baseline and 2 months post-intervention ]
    The FCCS is a unidimensional, Likert-type scale composed of 15 items. Each item response is in a Likert-type format with participants indicating their agreement with the item with 1 "not true at all" to 7 "very true." Item scores are summed and higher scores represent higher levels of conflict within a family.

  4. Change in SS Upper Extremity (UE) Self Efficacy using Confidence in Hand and Movement Scale (CAHM) score [ Time Frame: Baseline and 2 months post-intervention ]
    Confidence in Hand and Movement Scale (CAHM) is 20-item (scale 0-100) upper extremity confidence for functional tasks. High scores represent high confidence.

  5. Family Assessment Device (FAD) Scale Score [ Time Frame: Baseline ]
    The 12-item General Family Functioning scale from the McMaster Family Assessment Device measures general family functioning. The Family Assessment Device is recommended as an assessment measure for families of stroke survivors. Higher scores indicate ineffective family functioning.

  6. Change in Caregiver Strain assessed by the Caregiver Strain Index (CSI) [ Time Frame: Baseline and 2 months post-intervention ]
    The CSI is a 13-question tool that measures strain related to care provision. There is at least one item for each of the following major domains: Employment, Financial, Physical, Social and Time. Positive responses to seven or more items on the index indicate a greater level of strain. Scoring ranges from 0 to 26, with 0 indicating no caregiver strain and 26 indicating extreme strain

  7. Change in Bakas Caregiving Outcomes Scale (BCOS) Score [ Time Frame: Baseline and 2 months post-intervention ]
    The BCOS is a unidimensional scale based on 10 items and addresses changes in caregiving social functioning, subjective well-being and physical health. Participants respond to statements on a 7-point Likert scale (1=changed for the worst, 7=changed for the best).

  8. Upper Extremity Impairment assessed by the Fugl-Meyer Assessment (FMA) [ Time Frame: Baseline ]
    Upper extremity impairment will be assessed by the Fugl-Meyer Assessment (FMA). The FMA evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale. The maximum score is 66 points. Higher score indicates higher arm function.

  9. Change in stroke survivor quality of life assessed by Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities [ Time Frame: Baseline ]

    Stroke survivor quality of life and social participation will be assessed by the Neuro-QoL Short Form v1.1 - Satisfaction with Social Roles and Activities, an 8- item, Likert-type scale involving satisfaction in the last 7 days.

    All Neuro-QoL scores should be presented as T-scores. The T-score is the standardized score with a mean of 50 and standard deviation of 10. Raw scores should only be reported for uncalibrated items (i.e., item pools). Having T-scores in publications facilitates comparisons between studies.


  10. Change in Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression- Short Form 6a Score [ Time Frame: Baseline and 2 months post-intervention ]
    Depressive symptoms among caregivers will be assessed with the 6-item PROMIS Depression- Short Form 6a instrument. Responses are given on a scale from 1 to 5 where 1 = never and 5 = always. Total scores range from 6 to 30 where higher scores indicate greater feelings of depression.

  11. Change in Upper Extremity Function-Fine Motor/ ADL will be assessed by Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) [ Time Frame: Baseline, 2 months post-intervention ]
    The Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) is an 8-item upper extremity function measure, Likert-type scale All Neuro-QoL scores should be presented as T-scores. The T-score is the standardized score with a mean of 50 and standard deviation of 10. Raw scores should only be reported for uncalibrated items (i.e., item pools).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Stroke Survivors (SS):

  • 1-3 months post ischemic or hemorrhagic event
  • discharged from inpatient neurologic rehabilitation to their home
  • have minimal to moderate UE deficits (actively initiate 20 degrees of wrist and 10 degrees of finger extension)
  • no severe cognitive deficits (Mini -mental test >24)
  • no physician determined major medical problems that would limit participation in outpatient therapy

Inclusion Criteria for Carepartners (CP):

  • spouse/partner or family member
  • dwelling in the same household
  • self-identify as the primary caregiver of the SS
  • >21 years old
  • able to read and write English
  • have no significant cognitive deficits (Mini -mental test >24)
  • familiar with using a computer and accessing websites, or with using a tablet

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040751


Contacts
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Contact: Sarah Blanton, PT, DPT 404-712-2222 sblanto@emory.edu

Locations
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United States, Georgia
Emory Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sarah Blanton, PT, DPT    404-712-2222    sblanto@emory.edu   
Sponsors and Collaborators
Emory University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Sarah Blanton, PT, DPT Emory University
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Responsible Party: Sarah Blanton, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT04040751    
Other Study ID Numbers: IRB00107906
R21NR018015 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, will be shared after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following final publication of the results of the aims.
Access Criteria: Researchers who provide a methodologically sound proposal and whose proposed use of data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Proposals should be directed to sarah.blanton@emory.edu. To gain access, data requestors will need to sign a data access agreement. The data agreement will be reviewed by the investigative team for approval.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Blanton, Emory University:
Telehealth
Rehabilitation
Care partner
Sub-acute stroke
CARE-CITE
Stroke survivors
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases