Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke

NCT04040751 | Completed Results

• 2 other identifiers: IRB00107906R21NR018015
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Carepartner and Collaborative Integrated Therapy (CARE-CITE) is a novel, web-based carepartner focused intervention 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.

Conditions

Stroke

Keywords

Telehealth; Rehabilitation; Care partner; Sub-acute stroke; CARE-CITE; Stroke survivors

Outcome Measures

Primary Outcomes (6)

• Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners

  Depression among carepartners was assessed with the CES-D. The CES-D is 20-item, 4-point Likert-type scale where 0 = none/rare and 3 = most or all of the time. The scoring of positive items is reversed. The possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology. Unadjusted means are presented here.

  Baseline, 2 months post-intervention

• Short Form Health Survey (SF-36) Scale Score Among Carepartners

  Carepartner quality of life was assessed with the SF-36. The 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. Lower scores indicate greater disability, while higher scores indicate less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Unadjusted means are presented here.

  Baseline, 2 months post-intervention

• Wolf Motor Function Test (WMFT) Upper Extremity Function Ability Score (FAS)

  The Wolf Motor Function Test (WMFT) assesses upper extremity motor ability with 17 timed and functional tasks (15 timed and 2 strength tasks). Functional ability for each task is scored from 0 to 5, where 0 = does not attempt with upper extremity being tested, and 5 = movement appears to be normal. Total scores range from 0 to 85 and lower scores indicate lower functional ability. Unadjusted means are presented here.

  Baseline, 2 months post-intervention

• Wolf Motor Function Test (WMFT) Test Time Among Stroke Survivors

  The Wolf Motor Function Test (WMFT) assesses upper extremity motor ability with 17 functional tasks (15 timed and 2 strength tasks). The time, in seconds, required to complete each of 15 timed scores is calculated, with lower times (faster speeds) indicating higher functioning levels. Unadjusted means are presented here.

  Baseline, 2 months post-intervention

• Quality of Upper Extremity Function by Motor Activity Log (MAL) Score Among Stroke Survivors

  The Motor Activity Log is 30-item questionnaire assessing use of the affected arm during normal daily activities. Responses are given on a Likert scale where 0 = the weaker arm was not used at all for that activity (never) to 5 = the ability to use the weaker arm for that activity was as good as before the stroke (normal). The total score is the average of all items and ranges from 0 to 5, where higher values indicate greater function of the arm that was impacted by the stroke. Unadjusted means are presented here.

  Baseline, 2 months post-intervention

• Stroke Impact Scale (SIS) Score Among Stroke Survivors

  Quality of life among stroke survivors was assessed with the Stroke Impact Scale (SIS). The SIS is a stroke specific, self report questionnaire (59 items across 8 domains) that measures how a stroke has impacted a participant's health and life, including strength, memory and thinking, emotions and mood, communication, activities of daily living, mobility, function of affected upper extremity, and social participation. Each item is rated in a 5-point Likert scale in terms of the difficulty the participant has experienced in completing each item. A score for each domain is obtained, ranging from 0 to 100 where higher scores indicate greater ability to perform tasks. Unadjusted means are presented here.

  Baseline, 2 months post-intervention

Secondary Outcomes (11)

• Family Care Climate Questionnaire - Carepartners (FCCQ-CP) Score

  Baseline, 2 months post-intervention

• Family Care Climate Questionnaire - Stroke Survivor (FCCQ-SS) Score

  Baseline, 2 months post-intervention

• Family Caregiver Conflict Scale (FCCS) Score Among Carepartners

  Baseline, 2 months post-intervention

• Confidence in Hand and Movement Scale (CAHM) Score

  Baseline, 2 months post-intervention

• Family Assessment Device (FAD) Scale Score Among Carepartners

  Baseline

Study Arms (4)

CARE-CITE Carepartner

EXPERIMENTAL

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

Control Carepartners

ACTIVE COMPARATOR

Carepartners in this study arm receive customary care outpatient rehabilitation therapy but no CARE-CITE intervention. The carepartner 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

CARE-CITE Stroke Survivor

EXPERIMENTAL

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

Control Stroke Survivors

ACTIVE COMPARATOR

Stroke survivors in this study arm receive customary care outpatient rehabilitation therapy but no CARE-CITE intervention. Carepartners of the stroke survivors 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

Interventions

CARE-CITE BEHAVIORAL

The primary CARE-CITE components will be education via web platform. Carepartners complete 6 online CARE-CITE modules (15-30-minute sessions each). The 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.

CARE-CITE Carepartner; CARE-CITE Stroke Survivor

Standard of care BEHAVIORAL

The carepartner will receive a support brochure with general caregiving information including website resources to mimic web interaction of intervention group (e.g., stroke caregiver resource site).

Control Carepartners; Control Stroke Survivors

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• months post ischemic or hemorrhagic event
• discharged from inpatient neurologic rehabilitation to their home
• have minimal to moderate upper extremity (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
• spouse/partner or family member
• dwelling in the same household
• self-identify as the primary caregiver of the stroke survivor
• \>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

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Sarah Blanton, PT, DPT
• Organization: Emory University

sblanto@emory.edu

404-712-2222

Study Officials

• Sarah Blanton, PT, DPT

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: August 9, 2019
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: January 19, 2023
• Results First Posted: January 19, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)