NCT02772445

Brief Summary

The purpose of this study is to refine STROKE-CARE for caregivers and explore changes in caregiver and care-recipient outcomes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

March 31, 2016

Last Update Submit

July 1, 2021

Conditions

Stroke

Keywords

EmpowermentCaregiver

Outcome Measures

Primary Outcomes (1)

  • The proportion of caregivers that use the universal strategy in daily activities

    after study completion, an average of 6 weeks

Study Arms (1)

STROKE-CARE Intervention

EXPERIMENTAL

In STROKE-CARE, caregivers will learn a problem-solving strategy. Participants will receive approximately 10 sessions by an occupational therapist in the home over a 5 week process.

Behavioral: STROKE-CARE

Interventions

STROKE-CAREBEHAVIORAL

In STROKE-CARE, caregivers will learn a problem-solving strategy. They will (1) identify barriers to performance, (2) generate strategies to address barriers, and (3) apply these strategies to support care-recipients in occupations.

STROKE-CARE Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Primary caregiver for an individual post-stroke
  • Live with the care-recipient
  • Provide 1 hour of caregiving per day
  • Subjective caregiver burden

You may not qualify if:

  • non-English speaking
  • Active treatment (chemotherapy, radiation therapy) for cancer
  • Imminent placement of care-recipient into a nursing home or with another caregiver (within 6 months)
  • Involvement in another clinical trial for caregivers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15221, United States

Location

MeSH Terms

Conditions

StrokeEmpowerment

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 31, 2016

First Posted

May 13, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Study Completion

December 1, 2018

Last Updated

July 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)