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Clinical Trials/NCT04040751
NCT04040751
Completed
Not Applicable

Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke

Emory University1 site in 1 country46 target enrollmentAugust 9, 2019
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Emory University
Enrollment
46
Locations
1
Primary Endpoint
Center for Epidemiologic Studies - Depression (CES-D) Scale Score Among Carepartners
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

Stroke is a leading cause of serious, long-term disability in the United States, and has a particularly harmful impact on individuals and families. Approximately 4.8 million stroke survivors require assistance from family members who are often untrained and ill prepared for the burdens associated with stroke rehabilitation. Family carepartners are key contributors to stroke recovery, but their efforts can lead them to experience a high level of burden and depressive symptoms, reduced quality of life and increased stress in the context of high levels of family conflict surrounding the recovery process. Rehabilitation therapy interventions have primarily targeted stroke survivor outcomes without specifically addressing the well-being of the carepartner. The researchers of this study have developed a theory-based, family-centered intervention, Carepartner and Collaborative Integrated Therapy (CARE-CITE), designed to engage carepartners during stroke survivor upper extremity (UE) functional task practice in the home. Residual UE impairments occur in up to 80% of stroke survivors and are a primary factor in loss of functional independence. CARE-CITE guides the carepartner in collaborative goal setting and providing autonomy support (characterized by empathy, choice and reducing use of controlling language) for the stroke survivor to promote motivation and creative problem solving in UE self-management. Participating stroke survivor and carepartner dyads will be randomized to receive the CARE-CITE intervention with usual customary care, or usual customary care alone for four weeks.

Registry
clinicaltrials.gov
Start Date
August 9, 2019
End Date
December 21, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Blanton

Professor

Emory University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: Baseline, 2 months post-intervention

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.

Stroke Impact Scale (SIS) Score Among Stroke Survivors

Time Frame: Baseline, 2 months post-intervention

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.

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

Time Frame: Baseline, 2 months post-intervention

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.

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

Time Frame: Baseline, 2 months post-intervention

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.

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

Time Frame: Baseline, 2 months post-intervention

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.

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

Time Frame: Baseline, 2 months post-intervention

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.

Secondary Outcomes

  • 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 Assessment Device (FAD) Scale Score Among Carepartners(Baseline)
  • Bakas Caregiving Outcomes Scale (BCOS) Score(Baseline, 2 months post-intervention)
  • Family Caregiver Conflict Scale (FCCS) Score Among Carepartners(Baseline, 2 months post-intervention)
  • Fugl-Meyer Assessment (FMA) Upper Extremity Motor Score(Baseline, 2 months post-intervention)
  • Caregiver Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 6a Score(Baseline, 2 months post-intervention)
  • Caregiver Strain Index (CSI) Score(Baseline, 2 months post-intervention)
  • Neuro-QOL SF v1.0 - Upper Extremity Function (Fine Motor, ADL) Score(Baseline, 2 months post-intervention)
  • Confidence in Hand and Movement Scale (CAHM) Score(Baseline, 2 months post-intervention)
  • Neuro-QoL Short Form v1.1 - Satisfaction With Social Roles and Activities Score Among Stroke Survivors(Baseline, 2 months post-intervention)

Study Sites (1)

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