Feasibility of a Stroke Specific Self-management Program

Stroke Clinical Trial

Official title:

Feasibility of a Stroke Specific Self-management Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03993574
• Other study ID #: 19-0006
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 3, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Conditions
• Stroke

Intervention

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
• Standard care
All stroke patients being discharged from the acute hospital receive the following care: 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. A stroke clinic appointment that is set to occur 90-days post discharge. 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. Information on local support groups. Referrals to start physical, occupational or speech therapy, if recommended by their physician.

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	National Center for Advancing Translational Science (NCATS), The Claude D. Pepper Older Americans Independence Centers

Country where clinical trial is conducted

United States, 

References & Publications (31)

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. — View Citation

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.

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. — View Citation

Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez 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. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(®) 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Living a Healthy Life with Chronic Conditions, 4th Edition. https://www.bullpub.com/living-a-healthy-life-with-chronic-conditions-4th-edition.html

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.

Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. Review. — View Citation

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. — View Citation

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. — View Citation

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després 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. Erratum in: Circulation. 2015 Jun 16;131(24):e535. Circulation. 2016 Feb 23;133(8):e417. — View Citation

Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015 Apr 21;10:53. doi: 10.1186/s13012-015-0242-0. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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 2 (3 months) to follow-up (2 weeks from last day of intervention)
Primary	Feasibility: Patients Screened	number of patients screened	Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
Primary	Feasibility: Eligible Patients	number of patients eligible	Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
Primary	Feasibility: Patients Approached	number of patients approached	Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
Primary	Feasibility: Patients Enrolled	number of patients enrolled	Collected at baseline 1 (24 hours prior to the patients' discharge from acute care)
Primary	Feasibility: Patient Refusals	number of patient refusals	Collected at follow-up (2 weeks from last day of intervention)
Primary	Feasibility: Patient Withdrawals	number of patient withdrawals	Collected at follow-up (2 weeks from last day of intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)