Feasibility of a Stroke Specific Self-management Program

NCT03993574 | Unknown

• 1 other identifier: 19-0006
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Chronic Conditions

Outcome Measures

Primary Outcomes (6)

• Feasibility: Patients Screened

  number of patients screened

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

• Feasibility: Eligible Patients

  number of patients eligible

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

• Feasibility: Patients Approached

  number of patients approached

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

• Feasibility: Patients Enrolled

  number of patients enrolled

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

• Feasibility: Patient Refusals

  number of patient refusals

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

• Feasibility: Patient Withdrawals

  number of patient withdrawals

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

Secondary Outcomes (8)

• Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire

  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

  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

  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

  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

  change in sleep from base line 1 (24 hours prior to discharge from acute care), base line 2 (3 months)

Other Outcomes (2)

• Change in self-reported health distress, as measured by the Health Distress Questionnaire

  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

  change in health distress from base line 2 (3 months) to follow-up (2 weeks from last day of intervention)

Study Arms (2)

Standard Care

OTHER

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

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

Interventions

Self- management program OTHER

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

Experimental

Standard care OTHER

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• The Claude D. Pepper Older Americans Independence Centers: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

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MeSH Terms

Conditions

Stroke; Chronic Disease

Interventions

Self-Management; Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Timothy Reistetter, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: September 3, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)