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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| The Claude D. Pepper Older Americans Independence Centers | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-reported health distress, as measured by the Health Distress Questionnaire | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Reistetter, PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28122885 | Background | Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. | |
| 28880858 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 21, 2022 | |
| Reset | Apr 14, 2022 | |
| Release | Sep 25, 2023 | |
| Reset | Oct 19, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 21, 2022 | Apr 14, 2022 | |||
| Sep 25, 2023 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000073278 | Self-Management |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D019984 | Quality Indicators, Health Care |
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|
| Standard care | Other | All stroke patients being discharged from the acute hospital receive the following care:
|
|
| Change in self-reported self-management, as measured by the Southampton Stroke Self-Management Questionnaire | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
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) |
| Background |
| Yang Q, Tong X, Schieb L, Vaughan A, Gillespie C, Wiltz JL, King SC, Odom E, Merritt R, Hong Y, George MG. Vital Signs: Recent Trends in Stroke Death Rates - United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017 Sep 8;66(35):933-939. doi: 10.15585/mmwr.mm6635e1. |
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| 25520374 | Background | Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available. |
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| Oct 19, 2023 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |