Feasibility of a Stroke Specific Self-management Program
NCT ID: NCT03993574
Last Updated: 2021-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
28 participants
INTERVENTIONAL
2019-09-03
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard Care
The standard care group will receive baseline testing #1, standard care, baseline testing #2 and follow up testing approximately 8 weeks later.
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 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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* at least one chronic medical condition
* must be able to consent independently
* be alert and oriented x 3
* be ≥ 18 years old
Exclusion Criteria
* they do not speak English
* discharged from acute care to nursing home
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Center for Advancing Translational Sciences (NCATS)
NIH
The Claude D. Pepper Older Americans Independence Centers
OTHER
The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Timothy Reistetter, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Texas Medical Branch
Galveston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.
Boger EJ, Hankins M, Demain SH, Latter SM. Development and psychometric evaluation of a new patient -reported outcome measure for stroke self -management: The Southampton Stroke Self - Management Questionnaire (SSSMQ). Health Qual Life Outcomes. 2015 Oct 3;13:165. doi: 10.1186/s12955-015-0349-7.
Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(R) measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017 Jul;26(7):1915-1924. doi: 10.1007/s11136-017-1527-3. Epub 2017 Feb 26.
Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.
Rine RM, Roberts D, Corbin BA, McKean-Cowdin R, Varma R, Beaumont J, Slotkin J, Schubert MC. New portable tool to screen vestibular and visual function--National Institutes of Health Toolbox initiative. J Rehabil Res Dev. 2012;49(2):209-20. doi: 10.1682/jrrd.2010.12.0239.
Lorig K, Stewart A, Ritter P, González V, et al. Outcome Measures for Health Education and Other Health Care Interventions. Thousand Oaks, CA, US: Sage Publications, Inc; 1996.
Harris JR, Wallace RB. The Institute of Medicine's new report on living well with chronic illness. Prev Chronic Dis. 2012;9:E148. doi: 10.5888/pcd9.120126. No abstract available.
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.
Laver K, Halbert J, Stewart M, Crotty M. Patient readiness and ability to set recovery goals during the first 6 months after stroke. J Allied Health. 2010 Winter;39(4):e149-54.
Gallacher K, Morrison D, Jani B, Macdonald S, May CR, Montori VM, Erwin PJ, Batty GD, Eton DT, Langhorne P, Mair FS. Uncovering treatment burden as a key concept for stroke care: a systematic review of qualitative research. PLoS Med. 2013;10(6):e1001473. doi: 10.1371/journal.pmed.1001473. Epub 2013 Jun 25.
Allen K, Hazelett S, Jarjoura D, Wright KD, Clough L, Weinhardt J. Improving stroke outcomes: Implementation of a postdischarge care management model. J Clin Outcomes Manag. 2004;11(11):707-714.
Smith ML, Ory MG, Ahn S, Kulinski KP, Jiang L, Horel S, Lorig K. National dissemination of chronic disease self-management education programs: an incremental examination of delivery characteristics. Front Public Health. 2015 Apr 27;2:227. doi: 10.3389/fpubh.2014.00227. eCollection 2014.
Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001 Nov;39(11):1217-23. doi: 10.1097/00005650-200111000-00008.
Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.
Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
Jones F, Riazi A. Self-efficacy and self-management after stroke: a systematic review. Disabil Rehabil. 2011;33(10):797-810. doi: 10.3109/09638288.2010.511415. Epub 2010 Aug 27.
Kralik D, Koch T, Price K, Howard N. Chronic illness self-management: taking action to create order. J Clin Nurs. 2004 Feb;13(2):259-67. doi: 10.1046/j.1365-2702.2003.00826.x.
Ahn S, Basu R, Smith ML, Jiang L, Lorig K, Whitelaw N, Ory MG. The impact of chronic disease self-management programs: healthcare savings through a community-based intervention. BMC Public Health. 2013 Dec 6;13:1141. doi: 10.1186/1471-2458-13-1141.
Boger EJ, Demain S, Latter S. Self-management: a systematic review of outcome measures adopted in self-management interventions for stroke. Disabil Rehabil. 2013 Aug;35(17):1415-28. doi: 10.3109/09638288.2012.737080. Epub 2012 Nov 21.
Jones F, Mandy A, Partridge C. Changing self-efficacy in individuals following a first time stroke: preliminary study of a novel self-management intervention. Clin Rehabil. 2009 Jun;23(6):522-33. doi: 10.1177/0269215508101749. Epub 2009 Apr 29.
Harwood M, Weatherall M, Talemaitoga A, Barber PA, Gommans J, Taylor W, McPherson K, McNaughton H. Taking charge after stroke: promoting self-directed rehabilitation to improve quality of life--a randomized controlled trial. Clin Rehabil. 2012 Jun;26(6):493-501. doi: 10.1177/0269215511426017. Epub 2011 Nov 15.
Boger EJ, Demain SH, Latter SM. Stroke self-management: a focus group study to identify the factors influencing self-management following stroke. Int J Nurs Stud. 2015 Jan;52(1):175-87. doi: 10.1016/j.ijnurstu.2014.05.006. Epub 2014 May 24.
Battersby M, Hoffmann S, Cadilhac D, Osborne R, Lalor E, Lindley R. 'Getting your life back on track after stroke': a Phase II multi-centered, single-blind, randomized, controlled trial of the Stroke Self-Management Program vs. the Stanford Chronic Condition Self-Management Program or standard care in stroke survivors. Int J Stroke. 2009 Apr;4(2):137-44. doi: 10.1111/j.1747-4949.2009.00261.x.
Cadilhac DA, Hoffmann S, Kilkenny M, Lindley R, Lalor E, Osborne RH, Batterbsy M. A phase II multicentered, single-blind, randomized, controlled trial of the stroke self-management program. Stroke. 2011 Jun;42(6):1673-9. doi: 10.1161/STROKEAHA.110.601997. Epub 2011 Apr 14.
Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015 Apr 21;10:53. doi: 10.1186/s13012-015-0242-0.
Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A conceptual framework for implementation fidelity. Implement Sci. 2007 Nov 30;2:40. doi: 10.1186/1748-5908-2-40.
Living a Healthy Life with Chronic Conditions, 4th Edition. https://www.bullpub.com/living-a-healthy-life-with-chronic-conditions-4th-edition.html
Rees G, Keeffe JE, Hassell J, Larizza M, Lamoureux E. A self-management program for low vision: program overview and pilot evaluation. Disabil Rehabil. 2010;32(10):808-15. doi: 10.3109/09638280903304193.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
19-0006
Identifier Type: -
Identifier Source: org_study_id