BMC Health Services Research | |
Randomized clinical trial of the timing it right stroke family support program: research protocol | |
Angela M Cheung9  Steve J Phillips7  Frank L Silver8  Maria Huijbregts1,10  Anna Czerwonka4  Theresa Green1  Grace Warner5  Mark Bayley2  Monique A M Gignac6  Gary Naglie3  Jill I Cameron4  | |
[1] Faculty of Nursing, University of Calgary, 2500 University Dr NW, Calgary AB T2N 1N4, Canada;Department of Medicine, University of Toronto, Toronto Canada;Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada;UHN Toronto Rehabilitation Institute, Toronto, Canada;School of Occupational Therapy, Dalhousie University, 5689 University Ave, Halifax, Nova Scotia B3H 3J5, Canada;Dalla Lana School of Public Health, University of Toronto, Toronto, Canada;Department of Medicine, Division of Neurology, Dalhousie University/QEII Health Sciences Centre, 1796 Summer Street, Halifax, Nova Scotia B3H 3A7, Canada;UHN Toronto Western Hospital, 399 Bathurst Street, Toronto, ON M5T 2S8, Canada;Department of Medicine, University of Toronto, Toronto, Canada;Department of Physical Therapy, University of Toronto, Baycrest Health Sciences, Toronto, Canada | |
关键词: Longitudinal; Education; Social support; Randomized controlled trial; Mixed methods; Caregiver; Stroke; | |
Others : 1134321 DOI : 10.1186/1472-6963-14-18 |
|
received in 2013-06-13, accepted in 2014-01-06, 发布年份 2014 | |
【 摘 要 】
Background
Family caregivers provide invaluable support to stroke survivors during their recovery, rehabilitation, and community re-integration. Unfortunately, it is not standard clinical practice to prepare and support caregivers in this role and, as a result, many experience stress and poor health that can compromise stroke survivor recovery and threaten the sustainability of keeping the stroke survivor at home. We developed the Timing it Right Stroke Family Support Program (TIRSFSP) to guide the timing of delivering specific types of education and support to meet caregivers’ evolving needs. The objective of this multi-site randomized controlled trial is to determine if delivering the TIRSFSP across the stroke care continuum improves caregivers’ sense of being supported and emotional well-being.
Methods/design
Our multi-site single-blinded randomized controlled trial will recruit 300 family caregivers of stroke survivors from urban and rural acute care hospitals. After completing a baseline assessment, participants will be randomly allocated to one of three groups: 1) TIRSFSP guided by a stroke support person (health care professional with stroke care experience), delivered in-person during acute care and by telephone for approximately the first six to 12 months post-stroke, 2) caregiver self-directed TIRSFSP with an initial introduction to the program by a stroke support person, or 3) standard care receiving the educational resource “Let’s Talk about Stroke” prepared by the Heart and Stroke Foundation. Participants will complete three follow-up quantitative assessments 3, 6, and 12-months post-stroke. These include assessments of depression, social support, psychological well-being, stroke knowledge, mastery (sense of control over life), caregiving assistance provided, caregiving impact on everyday life, and indicators of stroke severity and disability. Qualitative methods will also be used to obtain information about caregivers’ experiences with the education and support received and the impact on caregivers’ perception of being supported and emotional well-being.
Discussion
This research will determine if the TIRSFSP benefits family caregivers by improving their perception of being supported and emotional well-being. If proven effective, it could be recommended as a model of stroke family education and support that meets the Canadian Stroke Best Practice Guideline recommendation for providing timely education and support to families through transitions.
Trial registration
ClinicalTrials.gov: NCT00958607.
【 授权许可】
2014 Cameron et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20150305155448511.pdf | 553KB | download | |
Figure 2. | 117KB | Image | download |
Figure 1. | 57KB | Image | download |
【 图 表 】
Figure 1.
Figure 2.
【 参考文献 】
- [1]Heart and Stroke Foundation.2013 Stroke Report. http://www.heartandstroke.com/atf/cf/%7B99452D8B-E7F1-4BD6-A57D-B136CE6C95BF%7D/StrokeReport2013_ENG.pdf webcite
- [2]Mayo NE, Wood-Dauphinee S, Cote R, Durcan L, Carlton J: Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil 2002, 83:1035-1042.
- [3]Smith JE, Smith DL: No map, no guide. Family caregivers’ perspectives on their journeys through the system. Care Manag J 2000, 2:27-33.
- [4]Schulz R, O'Brien AT, Bookwala J, Fleissner K: Psychiatric and physical morbidity effects of dementia caregiving: prevalence, correlates, and causes. Gerontologist 1995, 35:771-791.
- [5]Pinquart M, Sorensen S: Differences between caregivers and noncaregivers in psychological health and physical health: a meta-analysis. Psychol Aging 2003, 18:250-267.
- [6]Han B, Haley WE: Family caregiving for patients with stroke. Review and analysis. Stroke 1999, 30:1478-1485.
- [7]Evans RL, Bishop DS, Haselkorn JK: Factors predicting satisfactory home care after stroke. Arch Phys Med Rehabil 1991, 72:144-147.
- [8]Kao HF, McHugh ML: The role of caregiver gender and caregiver burden in nursing home placements for elderly Taiwanese survivors of stroke. Res Nurs Health 2004, 27:121-134.
- [9]Arai Y, Sugiura M, Washio M, Miura H, Kudo K: Caregiver depression predicts early discontinuation of care for disabled elderly at home. Psychiatry Clin Neurosci 2001, 55:379-382.
- [10]Clarke A, Rosen R: Length of stay. How short should hospital care be? Eur J Public Health 2001, 11:166-170.
- [11]Wilkins K, Park E: Home care in Canada. Health Rep 1998, 10:29-37.
- [12]Bergman H, Beland F, Lebel P, Contandriopoulos AP, Tousignant P, Brunelle Y, et al.: Care for Canada’s frail elderly population: fragmentation or integration? CMAJ 1997, 157:1116-1121.
- [13]Visser-Meily A, van Heugten C, Post M, Schepers V, Lindeman E: Intervention studies for caregivers of stroke survivors: a critical review. Patient Educ Couns 2005, 56:257-267.
- [14]Greenwood N, Mackenzie A, Cloud GC, Wilson N: Informal primary carers of stroke survivors living at home - challenges, satisfactions and coping: a systematic review of qualitative studies. Disabil Rehabil 2008, 31:1-15.
- [15]Cameron JI, Naglie G, Silver FL, Gignac MA: Stroke family caregivers’ support needs change across the care continuum: a qualitative study using the timing it right framework. Disabil Rehabil 2013, 35:315-324.
- [16]Cameron JI, Gignac MA: “Timing It right”: a conceptual framework for addressing the support needs of family caregivers to stroke survivors from the hospital to the home. Patient Educ Couns 2008, 70:305-314.
- [17]Evans RL, Matlock AL, Bishop DS, Stranahan S, Pederson C: Family intervention after stroke: does counseling or education help? Stroke 1988, 19:1243-1249.
- [18]Lincoln NB, Francis VM, Lilley SA, Sharma JC, Summerfield M: Evaluation of a stroke family support organiser: a randomized controlled trial. Stroke 2003, 34:116-121.
- [19]Grant JS, Elliott TR, Weaver M, Bartolucci AA, Giger JN: Telephone intervention with family caregivers of stroke survivors after rehabilitation. Stroke 2002, 33:2060-2065.
- [20]van den Heuvel ET, Witte LP, Stewart RE, Schure LM, Sanderman R, Meyboom-de Jong B: Long-term effects of a group support program and an individual support program for informal caregivers of stroke patients: which caregivers benefit the most? Patient Educ Couns 2002, 47:291-299.
- [21]Braithwaite V, McGown A: Caregivers’ emotional well-being and their capacity to learn about stroke. J Adv Nurs 1993, 18:195-202.
- [22]Rodgers H, Atkinson C, Bond S, Suddes M, Dobson R, Curless R: Randomized controlled trial of a comprehensive stroke education program for patients and caregivers. Stroke 1999, 30:2585-2591.
- [23]Dennis M, O’Rourke S, Slattery J, Staniforth T, Warlow C: Evaluation of a stroke family care worker: results of a randomised controlled trial. Br Med J 1997, 314:1071-1076.
- [24]Cohen S: Stress, social support, and disorder. In The meaning and measurement of social support. Edited by Veiel HOF, Baumann A. New York: Hemisphere Publishing Corporation; 1992:109-124.
- [25]Aneshensel CS, Stone JD: Stress and depression: a test of the buffering model of social support. Arch Gen Psychiatry 1982, 39:1392-1396.
- [26]Drentea P, Clay OJ, Roth DL, Mittelman MS: Predictors of improvement in social support: five-year effects of a structured intervention for caregivers of spouses with Alzheimer’s disease. Soc Sci Med 2006, 63:957-967.
- [27]Bass DM, Noelker LS, Rechlin LR: The moderating influence of service use on negative caregiving consequences. J Gerontol 1996, 51:S121-S131. Series B, Psychological Sciences & Social Sciences
- [28]Cutrona CE, Russell DW: Type of social support and specific stress: towards a theory of optimal matching. In Social support: an interactional view. Edited by Saranson BR, Saranson IG, Pierce GR. New York: Wiley; 1990:319-366.
- [29]Sorensen S, Pinquart M, Duberstein P: How effective are interventions with caregivers? An updated meta-analysis. Gerontologist 2002, 42:356-372.
- [30]Eames S, Hoffmann T, Worrall L, Read S, Wong A: Randomised controlled trial of an education and support package for stroke patients and their carers. BMJ Open 2013, 3:1-9.
- [31]King RB, Hartke RJ, Houle T, Lee J, Herring G, Exander-Peterson BS, et al.: A problem-solving early intervention for stroke caregivers: one year follow-up. Rehabil Nurs 2012, 37:231-243.
- [32]Teng J, Mayo NE, Latimer E, Hanley J, Wood-Dauphinee S, Cote R, et al.: Costs and caregiver consequences of early supported discharge for stroke patients. Stroke 2003, 34:528-536.
- [33]Sulch D, Melbourn A, Perez I, Kalra L: Integrated care pathways and quality of life on a stroke rehabilitation unit. Stroke 2002, 33:1600-1604.
- [34]Grant JS: Social problem-solving partnerships with family caregivers. Rehabil Nurs 1999, 24:254-260.
- [35]Boter H, for the HESTIA Study Group: Multicenter randomized controlled trial of an outreach nursing support program for recently discharged stroke patients. Stroke 2004, 35:2867-2872.
- [36]Kodner DL, Spreeuwenberg C: Integrated care: meaning, logic, applications, and implications: a discussion paper. Int J Int Care 2002, 2:1-8.
- [37]Reuben DB, Eng C, Pedulla J, Eleazer GP, McCann R, Fox N: Models of geriatric practice: program of all-inclusive care for the elderly (PACE): an innovative model of integrated geriatric care and financing. J Am Geriatr Soc 1997, 45:1-20.
- [38]Hebert R, Durand PJ, Dubuc N, Tourigny A: PRISMA: a new model of integrated service delivery for the frail older people in Canada. Int J Int Care 2003, 3:1-10.
- [39]Coleman EA, Parry C, Chalmers S, Min SJ: The care transitions intervention: results of a randomized controlled trial. Arch Intern Med 2006, 166:1822-1828.
- [40]Parry C, Coleman EA, Smith JD, Frank J, Kramer AM: The care transitions intervention: a patient-centered approach to ensuring effective transfers between sites of geriatric care. Home Health Care Serv Q 2003, 22:1-17.
- [41]Creswell J, Plano Clark V: Designing and conducting mixed methods research: second edition. 2nd edition. California: Sage Publications, Inc; 2011.
- [42]Jones F: Strategies to enhance chronic disease self-management: how can we apply this to stroke? Disabil Rehabil 2006, 28:841-847.
- [43]Lorig KR, Holman H: Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med 2003, 26:1-7.
- [44]Cameron JI, Naglie G, Green TL, Gignac MA, Bayley M, Huijbregts M, et al.: Development and pilot testing of the timing it right stroke family support program. 2014. Manuscript in preparation
- [45]Cameron JI, Franche RL, Cheung AM, Stewart DE: Lifestyle interference and emotional distress in family caregivers of advanced cancer patients. Cancer 2002, 94:521-527.
- [46]Cameron JI, Herridge MS, Tansey CM, McAndrews MP, Cheung AM: Well-being in informal caregivers of survivors of acute respiratory distress syndrome. Crit Care Med 2006, 34:81-86.
- [47]Cameron JI, Cheung AM, Streiner DL, Coyte PC, Stewart DE: Stroke survivor depressive symptoms are associated with family caregiver depression during the first 2 years poststroke. Stroke 2011, 42:302-306.
- [48]EmPOWER: EmPower health research inc. 2009. Ref Type: Computer Program
- [49]Sherbourne CD, Stewart AL: The MOS social support survey. Soc Sci Med 1991, 32:705-714.
- [50]Watson D, Clark LA, Tellegen A: Development and validation of brief measures of positive and negative affect: the PANAS scales. J Personal Soc Psychol 1988, 54:1063-1070.
- [51]Radloff LS: The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Measure 1977, 1:385-401.
- [52]Cameron JI, Cheung AM, Streiner DL, Coyte PC, Stewart DE: Stroke survivors’ behavioral and psychologic symptoms are associated with informal caregivers’ experiences of depression. Arch Phys Med Rehabil 2006, 87:177-183.
- [53]Sullivan K, Dunton NJ: Development and validation of the stroke knowledge test. Top Stroke Rehabil 2004, 11:19-28.
- [54]Pearlin LI, Schooler C: The structure of coping. J Health Soc Behav 1978, 19:2-21.
- [55]Pearlin LI, Mullan JT, Semple SJ, Skaff MM: Caregiving and the stress process: an overview of concepts and their measures. Gerontologist 1990, 30:583-594.
- [56]Browne GB, Arpin K, Corey P, Fitch M, Gafni A: Individual correlates of health service utilization and the cost of poor adjustment to chronic illness. Med Care 1990, 28:43-58.
- [57]Cote R, Battista RN, Wolfson C, Boucher J, Adam J, Hachinski V: The Canadian neurological scale: validation and reliability assessment. Neurology 1989, 39:638-643.
- [58]Wade DT, Hewer RL: Functional abilities after stroke: measurement, natural history and prognosis. J Neurol Neurosurg Psychiatry 1987, 50:177-182.
- [59]Sturges JE, Hanrahan KJ: Comparing telephone and face-to-face qualitative interviewing: a research note. Qual Res 2004, 4:107-118.
- [60]Rabiee F: Focus-group interview and data analysis. Proc Nutr Soc 2004, 63:655-660.
- [61]Ritchie J, Spencer L: Qualitative data analysis for applied policy research. In Analyzing qualitative data. Edited by Bryman A, Burgess RG. New York, NY: Routledge; 1994:173-194.
- [62]Tabachnick BG, Fidell LS: Using multivariate statistics. 3rd edition. New York, NY: HarperCollins College Publishers; 2001.
- [63]Creswell JW: Qualitative inquiry and research design: choosing among five traditions. London: Sage Publications; 1998.
- [64]McReynolds CJ, Koch LC, Rumrill PD Jr: Speaking of research. Qualitative research strategies in rehabilitation. Work 2001, 16:57-65.
- [65]Singer JD, Willett JB: Applied longitudinal data analysis: modeling change and event occurrence. New York: Oxford University Press, Inc; 2003.
- [66]NVivo qualitative data analysis software. [10.0]: QSR international Pty Ltd. 2012. Ref Type: Computer Program
- [67]Hsieh HF, Shannon SE: Three approaches to qualitative content analysis. Qual Health Res 2005, 15:1277-1288.
- [68]Neuendorf KA: The content analysis guidebook. Thousand Oaks (CA): Sage; 2002.
- [69]Lindsay MP, Gubitz G, Bayley M, Hill MD, Davies-Schinkel C, Singh S, et al.: Canadian best practice recommendations for stroke care (update 2010). Canadian stroke strategy best practices and standards writin group. Ottawa, Canada: Canadian Stroke Network; 2010. Ref Type: Report