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Clinical Trials/NCT03993574
NCT03993574
Unknown
Not Applicable

Feasibility of a Stroke Specific Self-management Program

The University of Texas Medical Branch, Galveston1 site in 1 country28 target enrollmentSeptember 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
The University of Texas Medical Branch, Galveston
Enrollment
28
Locations
1
Primary Endpoint
Feasibility: Patients Screened
Last Updated
4 years ago

Overview

Brief Summary

Stroke is a leading cause of disability, institutionalization, readmission and death. This research is being completed to accelerate the adoption of evidence-based therapy practices that improve overall stroke care and outcomes. We will implement a feasibility randomized controlled trial (RCT) studying the implementation of a stroke specific chronic disease self-management program. Specifically, if the person is identified to have a chronic vision impairment identified on the vision screen, a specific low vision self-management program will be used. Otherwise the program that will be used is the generic chronic disease self-management program.

Detailed Description

Approximately 75% of people are living with a prevalent chronic disease like diabetes or hypertension. Despite this high percentage, there is a projected increase of 37% by 2030. There are approximately 795,000 people sustaining a stroke each year, in the United States. Surviving a stroke can cost an estimated $34 billion dollars a year in medical costs and loss of productivity. While there is a sharp decline in mortality rate following stroke, the rate of long-term residual impairments, disabilities and risk for developing high rates of secondary chronic conditions remains high. People living with a new stroke can also have chronic conditions in their past medical histories. Management of prior and new conditions may not become evident until the stroke survivor has returned to the community and are no longer receiving medical services. Additionally, management of chronic conditions, especially for people who now are recovering from a stroke, may require different management plans altogether. The Center for Disease Control and Prevention called for a public health action to address chronic illness. One type of community rehabilitation intervention method is self-management. Self-management was first developed for well-elderly with chronic diseases. These programs support individuals managing their independently managing symptoms as well as help with the emotional and physical stress associated with chronic disease. Multiple research reports conclude that self-management interventions improve health outcomes, help with management of self-identity and reduce health care costs. There are existing stroke specific self-management programs, however minimal reported research regarding the best way to implement and measure a stroke specific chronic disease self-management program to optimize health outcomes and improve quality of life. Recently, a qualitative study concluded that any stroke specific self-management program should include 3 conceptual layers to address individual, external and environmental factors essential to enable successful implementation. The first conceptual layer is individual capacity or readiness to respond to the demands to self-management. The second is having external support for self-management. And the third is being in an environment that supports and facilitates success. Another study reported strong feasibility evidence for stroke specific self-management programs versus a standard program for community dwelling stroke survivors. A small study reported a program administered to stroke patients that led to changes in self-efficacy. Consistent with a feasibility study for implementing evidence based intervention, this project intends to address a need to bridge the translation gap between research evidence and clinical practice. This project intends to provide information to add to existing literature regarding implementation. Thus we plan to use the Determinant Framework, which will help specify determinants which act as barriers and enablers that influence implementation outcomes. Additionally, implementation theories will help us assess the implementation context, as we plan to use a checklist to evaluate factors influencing implementation across different domains (e.g. fidelity). This study also intends to provide preliminary data regarding efficacy in order to determine if a stroke specific program was superior to standard care.

Registry
clinicaltrials.gov
Start Date
September 3, 2019
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Acute hospitalization due to diagnosis of stroke
  • at least one chronic medical condition
  • must be able to consent independently
  • be alert and oriented x 3
  • be ≥ 18 years old

Exclusion Criteria

  • unable to independently consent
  • they do not speak English
  • discharged from acute care to nursing home

Outcomes

Primary Outcomes

Feasibility: Patients Screened

Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)

number of patients screened

Feasibility: Patients Approached

Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)

number of patients approached

Feasibility: Patient Withdrawals

Time Frame: Collected at follow-up (2 weeks from last day of intervention)

number of patient withdrawals

Feasibility: Eligible Patients

Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)

number of patients eligible

Feasibility: Patients Enrolled

Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)

number of patients enrolled

Feasibility: Patient Refusals

Time Frame: Collected at follow-up (2 weeks from last day of intervention)

number of patient refusals

Secondary Outcomes

  • Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25(change in vision quality of life from base line 2 (3 months) to follow-up (2 weeks from last day of intervention))
  • Change in self-reported sleep, as measured by the PROMIS sleep disturbance and sleep-related impairments(change in sleep from base line 2 (3 months) to follow-up (2 weeks from last day of intervention))
  • Change in self-reported self-efficacy, as measured by the Patient Reported Outcome Measure Information System (PROMIS) self-efficacy scale(change in self-efficacy from base line 2 (3 months) to follow-up (2 weeks from last day of intervention))
  • Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire(change in self-management from base line 2 (3 months) to follow-up (2 weeks from last day of intervention))

Study Sites (1)

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