Goed toegerust niet uitgeblust: Een zelfhulpcursus voor werkenden belast met mantelzorg om mantelzorgstress en verminderd functioneren op het werk te voorkomen|
|- candidate number||23373|
|- NTR Number||NTR5528|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-nov-2015|
|- Secondary IDs||2014-213 |
|- Public Title||Goed toegerust niet uitgeblust: Een zelfhulpcursus voor werkenden belast met mantelzorg om mantelzorgstress en verminderd functioneren op het werk te voorkomen|
|- Scientific Title||Goed toegerust niet uitgeblust: Een zelfhulpcursus voor werkenden belast met mantelzorg om mantelzorgstress en verminderd functioneren op het werk te voorkomen [A self-help course for employed informal caregivers for reducing caregiver stress and impaired work functioning]|
|- hypothesis||It is predicted that the intervention will reduce levels of caregiver stress, impaired work functioning, distress, care-work interference, and care-family interference, in employed informal caregivers. Furthermore, it is predicted that the intervention reduces impaired work functioning because it minimizes caregiver stress (i.e., mediation effect). |
|- Healt Condition(s) or Problem(s) studied||Impaired work functioning, Caregivers|
|- Inclusion criteria||1.) Performance of informal care activities for a beloved one (e.g., father or mother, romantic partner or child, brother or sister, good friend, etc.), 2.) age 23 to 65 years, 3.) paid work, 4.) male or female.|
|- Exclusion criteria||Excluded are individuals who do not meet the inclusion criteria|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-nov-2015|
|- planned closingdate||1-nov-2016|
|- Target number of participants||150|
|- Interventions||The intervention will be assigned to the intervention group. It is a self-help course that consists of a workbook, and complementary E-health module developed and presented with Xerte online toolkits (Lockley & Reijnders, 2013), containing excercises, texts, and practical suggestions. The individuals who receive the intervention receive the course and choose and complete elements of the intervention that they consider relevant for their specific informal care situation. The intervention aims to 1) diminish role ambiguity by helping paid workers understand and shape the informal caregiver role, and b) diminish role conflict by helping paid workers combine informal care responsibilities with paid work activities. The materials for the intervention (in Dutch, and tailored for paid workers who have limited amounts of time and help individuals with varying health problems) are adapted versions of existing interventions. The intervention consists of elements adapted from 1) The 'Learning to be a family caregiver program (Ducharme et al., 2009, 2011), 2) a specific stress-management program (Eisen et al., 2008), 3.) The ADAPT-method (Nezu et al., 1998; Washington et al., 2011), 4) the role clarity intervention (Schaubroeck et al., 1993), and 5) general strategies for helping informal caregivers (e.g., Barbosa et al., 2011). No treatment is given to the individuals assigned to the comparison group (i.e., non-active and non-placebo control group) until after the final measurement in the research. |
|- Primary outcome||Caregiver stress (as measured with an adapted version of the Caregiver Strain Index of Robinson, 1983). |
|- Secondary outcome||Work functioning as measured with the composite weighted work functioning approach (Boezeman et al., 2015), distress as measured with the distress-subscale of Terluijn et al. (2002), interference of the caregiving activities with work and family as measured with an adapted version of the negative interference subscales of the SWING (Wagena & Geurts, 2000)|
|- Timepoints||Baseline measurement (T1; before assigning the intervention to the intervention group), follow-up measurement 4 weeks and 2 days after assigning the intervention to the intervention group (T2), and follow-up measurement 8 weeks and 2 days after assigning the intervention to the intervention group (T3) |
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES||Dr. Edwin Boezeman|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J. Sluiter|
|- Sponsor/Initiator ||Coronel Institute of Occupational Health, Academic Medical Center - University of Amsterdam (The Netherlands) |
(Source(s) of Monetary or Material Support)
|- Publications||Barbosa A, Figueiredo D, Sousa L, & Demain S. Coping with the caregiving role: Differences
between primary and secondary caregivers of dependent elderly people. Aging & Mental Health. 2011; 15: 490 – 499.
Boezeman EJ, Sluiter JK, Nieuwenhuijsen K. Measuring work functioning: Validity of a weighted composite work functioning approach. JOOR. 2015; 25: 537-542.
Ducharme F, et al. Development of an intervention program for Alzheimer’s family caregivers following diagnostic closure. Clinical Nursing Research. 2009; 18: 44-67.
Ducharme F, et al. “Learning to become a family caregiver” Efficacy of an intervention program for caregivers following diagnosis of dementia in a relative. The Gerontologist. 2011; 51: 484-494.
Eisen KP, Allen GJ, Bollash M, et al. Stress management in the workplace: A comparison of computer-based and an in-person stress-management intervention. Computers in Human Behavior. 2008; 24: 486-496.
Lockley P, Reijnders T. Xerte online toolkits: Installation Guide. University of Nottingham.
Meleis AI. Role insufficiency and role supplementation: A conceptual framework. Nursing Research. 1975; 24: 264-271.
Meleis AI, Sawyer LM, IM EO, Hilfinger Messias DK, Schumacher K. Experiencing transitions: An emerging middle-range theory. Adv Nurs Sci. 2000; 23: 12-28.
Nezu AM, Nezu CM, Friedman SH, Faddis S, & Houts PS. Helping cancer patients cope: A problem-solving approach. 1998; Washington DC: American Psychological Association.
Rizzo, J. R., House, R. J., & Lirtzman, S. I. (1970). Role conflict and ambiguity in complex
organizations. Administrative Science Quarterly, 15, 150-163.
Robinson, B. Validation of a caregiver strain index. Journal of Gerontology. 1983; 38: 344-348.
Schaubroeck J, Ganster DC, Sime WE, & Ditman D. A field experiment testing supervisory role clarification. Journal of Applied Psychology. 1993; 46: 1-24.
Terluin B, Terluin M, Prince K, Van Marwijk H. De vierdimensionale klachtenlijst (4DKL) spoort psychische problemen op. Huisarts & Wetenschap. 2008; 51: 251-255
Terluin B, Duijsens IJ: 4DKL-handleiding. Handleiding van de Vierdimensionale Klachtenlijst [4DSQ manual. Manual of the Four-Dimensional Symptom Questionnaire]. Leiderdorp: Datec; 2002.
Wagena E & Geurts S. SWING: Ontwikkeling en validering van de ‘Survey Werk-Thuis Interferentie-Nijmegen’ [SWING: Development and validation of the Survey
Work-home Interference-Nijmegen]. Gedrag & Gezondheid. 2000; 28: 138-158.
Washington KT, Demiris G, Parker Oliver D, Wittenberg-Lyles E, Crumb E. Qualitative evaluation of a problem-solving intervention for informal hospice caregivers. Palliative Medicine. 2011; 26: 1018-1024.
|- Brief summary||Employed informal carers (i.e., individuals who hold a paid job and perform informal care activities for a beloved one besides the performance of the paid job) regularly report stress due to their personal situation, and stress undermines the ability to function adequately at work. At the same time, employed informal carers tend to lack clarity about how to perform informal care (i.e., role ambiguity) and regularly have to deal with paid work and family responsibilities versus informal care responsibilities (i.e., role conflict). According to role theory (e.g., Meleis et al., 1975, 2000; Rizzo et al., 1970) such role ambiguity and role conflict represent main sources of stress, and by resolving these with the tailored intervention aimed at reducing role ambiguity and role conflict employed informal carers may experience less stress and a better functioning at work. |
|- Main changes (audit trail)|
|- RECORD||10-nov-2015 - 19-jan-2016|
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