Feasibility of a Stroke Specific Self-management Program

December 6, 2021 updated by: The University of Texas Medical Branch, Galveston
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standard Care
The standard care group will receive baseline testing #1, standard care, baseline testing #2 and follow up testing approximately 8 weeks later.
Other: Standard care

All stroke patients being discharged from the acute hospital receive the following care:

  1. 1 follow-up call within 2 weeks by a nurse coordinator. The call involves checking if medications were able to be filled and how the person is feeling.
  2. A stroke clinic appointment that is set to occur 90-days post discharge.
  3. A list of their personal medications and generic educational materials. The educational materials are standard forms located in the Epic system. It is the nurses' responsibility to choose what forms to provide, however it is mandatory that stroke risk factor information is included.
  4. Information on local support groups.
  5. Referrals to start physical, occupational or speech therapy, if recommended by their physician.
Experimental: Experimental
Experimental group will baseline testing #1, standard care, baseline testing #2 however then participate in a 6-week self-management intervention (either generic or vision specific self-management based) and then get 8 week follow up testing.
Other: Self- management program

The program sessions are either adapted from the Stanford Patient Education Research Center's program called the Chronic Disease Self-Management Program (CDSMP) or from a vision self-management program.

Despite which self-management program, the format for each session will include, review of educational materials (using the CDSMP book/article), discussion via a case vignette (which is always stroke related), and participation in an activity based on that session's topic. These group sessions will be 1.5 hours each week for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Patients Screened
Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
number of patients screened
Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
Feasibility: Eligible Patients
Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
number of patients eligible
Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
Feasibility: Patients Approached
Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
number of patients approached
Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
Feasibility: Patients Enrolled
Time Frame: Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
number of patients enrolled
Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
Feasibility: Patient Refusals
Time Frame: Collected at follow-up (2 weeks from last day of intervention)
number of patient refusals
Collected at follow-up (2 weeks from last day of intervention)
Feasibility: Patient Withdrawals
Time Frame: Collected at follow-up (2 weeks from last day of intervention)
number of patient withdrawals
Collected at follow-up (2 weeks from last day of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire
Time Frame: change in self- management from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months)
patient-reported outcome measure (PROM) of self-management competency following stroke, likert scale 1-6, higher scores on the scale equal less self-management skills
change in self- management from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months)
Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire
Time Frame: change in self-management from base line 2 (3 months) to follow-up (2 weeks from last day of intervention)
patient-reported outcome measure (PROM) of self-management competency following stroke, likert scale 1-6, higher scores on the scale equal less self-management skills
change in self-management 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
Time Frame: change in self-efficacy from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months)
Self-Efficacy for Managing: Daily Activities, Symptoms, Medications and Treatments, Emotions, and Social Interactions. Likert scale 1-5, higher scores on the scale equal better confidence
change in self-efficacy from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months)
Change in self-reported self-efficacy, as measured by the Patient Reported Outcome Measure Information System (PROMIS) self-efficacy scale
Time Frame: change in self-efficacy from base line 2 (3 months) to follow-up (2 weeks from last day of intervention)
Self-Efficacy for Managing: Daily Activities, Symptoms, Medications and Treatments, Emotions, and Social Interactions. Likert scale 1-5, higher scores on the scale equal better confidence
change in self-efficacy 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
Time Frame: change in sleep from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months)
qualitative aspects of sleep and wake function via Likert scale of 1-5, higher scores on the scale equal better sleep
change in sleep from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months)
Change in self-reported sleep, as measured by the PROMIS sleep disturbance and sleep-related impairments
Time Frame: change in sleep from base line 2 (3 months) to follow-up (2 weeks from last day of intervention)
qualitative aspects of sleep and wake function via Likert scale of 1-5, higher scores on the scale equal better sleep
change in sleep from base line 2 (3 months) to follow-up (2 weeks from last day of intervention)
Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25
Time Frame: change in vision quality of life from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months)
vision quality of life, likert scale 1-5, higher scores on the scale equal better visual function
change in vision quality of life from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months)
Change in self-reported vision, as measured by the national eye institute vision function questionnaire -25
Time Frame: change in vision quality of life from base line 2 (3 months) to follow-up (2 weeks from last day of intervention)
vision quality of life, likert scale 1-5, higher scores on the scale equal better visual function
change in vision quality of life from base line 2 (3 months) to follow-up (2 weeks from last day of intervention)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported health distress, as measured by the Health Distress Questionnaire
Time Frame: change in health distress from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months)
health distress, likert scale 0-5, higher scores on the scale equal more distress.
change in health distress from base line 1 (24 hours prior to discharge from acute care) to base line 2 (3 months)
Change in self-reported health distress, as measured by the Health Distress Questionnaire
Time Frame: change in health distress from base line 2 (3 months) to follow-up (2 weeks from last day of intervention)
health distress, likert scale 0-5, higher scores on the scale equal more distress.
change in health distress from base line 2 (3 months) to follow-up (2 weeks from last day of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

National Center for Advancing Translational Sciences (NCATS)
The Claude D. Pepper Older Americans Independence Centers

Investigators

  • Principal Investigator: Timothy Reistetter, PhD, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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