NCT04040751

Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
BEHAVIORAL	CARE-CITE	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.
BEHAVIORAL	Standard of care	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).

Timeline

• Start date: 2019-08-09
• Primary completion: 2021-12-21
• Completion: 2021-12-21
• First posted: 2019-08-01
• Last updated: 2023-01-19
• Results posted: 2023-01-19

Locations

1 site across 1 country: United States