Effectiveness of cultural competent diabetes education.|
|- candidate number||2762|
|- NTR Number||NTR1076|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-sep-2007|
|- Secondary IDs||06-081 |
|- Public Title||Effectiveness of cultural competent diabetes education.|
|- Scientific Title||Effectiveness of a diabetes education and counseling program for Turkish, Maroccan an Hindostani patients by bicultural eucatiors embedde in a multidisciplinary setting.|
|- ACRONYM||effectiveness cultural competent diabetes education|
|- hypothesis||An ethnic specific cultural approach, including an ethnic specific education programme and individual guidance by a bicultural educator as part of a multidisciplinair team has a benificila effect on glycaemic control in Turkisch, Maroccan and South Indian (Hindostani) type 2 diabetes patiŽnts.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- Inclusion criteria||1. Turkish, Maroccan or Hindostani type 2 diabetes mellitus patients;|
2. 18 years or older;
3. registerd in the diabetes centre.
|- Exclusion criteria||PatiŽnts who, according to their physician, are too ill to follow the program.|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-dec-2006|
|- planned closingdate||1-mrt-2009|
|- Target number of participants||300|
|- Interventions||Patients from the intervention group receive six educational group sessions given by bicultural health educators. The health educators wille make use of a diabetes education manual develeoped by the public health service Rotterdam for education of Turkish type 2 diabetes patiŽnts. Apart from the group education, the health educators will counsel the diabetes patients during the course of the study.|
|- Primary outcome||Change in HbA1c in favour of the intervention group.|
|- Secondary outcome||1. Diabetes related knowledge;|
2. reported behaviour of following diabetes related advices;
3. behavioural determinants (attitude, self efficacy, intention);
4. blood lipids (total cholesterol, HDL-cholesterol, triglyceride);
5. blood pressure;
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| PJM Uitewaal|
|- CONTACT for SCIENTIFIC QUERIES|| PJM Uitewaal|
|- Sponsor/Initiator ||Haaglanden Medical Center, The Hague|
(Source(s) of Monetary or Material Support)
|Sanofi-Aventis, Novo Nordisk Farma B.V. , DZH Haaglanden, Smith Kline Beecham, Farma B.V., Pfizer B.V.|
|- Publications||1. Uitewaal PJ, Lips P, Netelenbos JC. An analysis of bone structure in patients with hip fracture. Bone Miner. 1987 Oct;3(1):63-73. |
2. Lips P, Asscheman H, Uitewaal P, Netelenbos JC, Gooren L. The effect of cross-gender hormonal treatment on bone metabolism in male-to-female transsexuals. J Bone Miner Res. 1989 Oct;4(5):657-62.
3. van der Meulen P, Uitewaal PJ, Boomsma LJ, van Dijk P, Hermans AJ, van de Vijver P, Dijkstra B, van der Laan J. [Is the use of antipyretics to lower fever and prevent febrile convulsions in children advisable?] Ned Tijdschr Geneeskd. 1993 Jan 23;137(4):213-4. Dutch. No abstract available.
4. Uitewaal P, Bruijnzeels MA, Hoes A, Thomas S. Diabetes education on Turkish immigrant diabetics: predictors of compliance. Patient Educ Couns. 2005 May;57(2):158-61. PMID: 15911188 [PubMed - indexed for MEDLINE]
5. Uitewaal PJ, Goudswaard AN, Ubink-Veltmaat LJ, Bruijnzeels MA, Hoes AW, Thomas S. Cardiovascular risk factors in Turkish immigrants with type 2 diabetes mellitus: comparison with Dutch patients. Eur J Epidemiol. 2004;19(10):923-9. Erratum in: Eur J Epidemiol. 2004;19(12):1139. Ubnik-Veltmaat, Lielith J [corrected to Ubink-Veltmaat, Lielith J]. PMID: 15575350 [PubMed - indexed for MEDLINE]
6. Uitewaal PJ, Manna DR, Bruijnzeels MA, Hoes AW, Thomas S. Prevalence of type 2 diabetes mellitus, other cardiovascular risk factors, and cardiovascular disease in Turkish and Moroccan immigrants in North West Europe: a systematic review. Prev Med. 2004 Dec;39(6):1068-76. Review. PMID: 15539038 [PubMed - indexed for MEDLINE]
7. Uitewaal P, Bruijnzeels M, De Hoop T, Hoes A, Thomas S. Feasibility of diabetes peer education for Turkish type 2 diabetes patients in Dutch general practice. Patient Educ Couns. 2004 Jun;53(3):359-63. PMID: 15186875 [PubMed - indexed for MEDLINE]
8. Uitewaal PJ, Bruijnzeels MA, Bernsen RM, Voorham AJ, Hoes AW, Thomas S. Diabetes care in Dutch general practice: differences between Turkish immigrants and Dutch patients. Eur J Public Health. 2004 Mar;14(1):15-8. PMID: 15080384 [PubMed - indexed for MEDLINE]
9. Uitewaal PJ, AJ Voorham, Bruijnzeels MA, Berghout A, Bernsen RM, Trienekens PH, Hoes AW, Thomas S. No clear effect of diabetes education on glycaemic control for Turkish type 2 diabetes patients: a controlled experiment in general practice. Neth J Med 2005 Dec; 63 (11): 13-19.
10.Voorham AJJ, Uitewaal PJM, Bruijnzeels M. Het effect van voorlichting in de eigen taal aan Turkse diabetespatiŽnten. TSG. 2002; 80(8): 514-520.
11. Rutten GEHM, De Grauw WJC, Nijpels G, Goudswaard AN, Uitewaal PJM, Van der Does FEE, Heine RJ, Van Ballegooie E, Verduijn MM, Bouma M. NHG-Standaard diabetes type 2. Huisarts en Wet. 2006 Mar; 49(3): 137-152.
|- Brief summary||Summary
Rationale: The prevalence of type 2 diabetes (DM2) has increased significantly in the past ten years. Compared to the indigenous Dutch population, diabetes is two to five times more common in non-western ethnic minority groups. Most of the older immigrants live in a relatively traditional manner and their proficiency in the Dutch language is limited. As a result of communication problems Dutch physicians experience more difficulty in delivery op optimal diabetes care to patient of ethnic minority groups. A former study showed a poorer glyceamic control in Turkish DM2 patients compared to their Dutch counterparts, although a similar diabetes care was provided. DM2 is a complex disease and treatment usually demands for behavioural changes, and can only succeed in well cooperative patients. Therefore a good understanding of the illness by the patient is essential.
Furthermore advices as well as behavioural rules should be in line with the culture and social environment of the patients. We expect that a cultural competent education (education in the native language with respect to the patientsí culture) can improve the diabetes care to DM2 patients from non-western ethnic minority groups, and by that improve the patientsí compliance and the glycaemic control.
Objective of the study: Does an ethnic specific cultural approach, including an ethnic specific education programme and individual guidance by a bicultural educator as part of a multidisciplinary team, have a beneificial effect on the glycaemic control in Turkish Morroccan and South Indian (Hindostani) type 2 diabetes patients.
Study design: Waiting list controlled design. Aftre informed consent the patients are randomly assigned to either the intervention group or the waiting list (control) group. All patients receive usual care.
Study population: All Turkish, south Asian and Moroccan type 2 diabetes patients of 18 years or older and registerd in the diabetes centre are eligible. Excluded will be patients who, according to the physician, are too ill to follow the program.
Intervention. Patients from the intervention group receive six educational group sessions given by bicultural health educators. The health educators will make use of a diabetes education manual developed by the public health service Rotterdam for the education of Turkish type 2 diabetes patients. Apart from the group education, the health educators will counsel the diabetes patients during the course of the study.
Main study parameters/endpoints: The main effect parameter is change in HbA1c in favour of the intervention group.
Secundary study parameters are: diabetes related knowledge,
Reported behaviour of following diabetes related advices, Behavioural determinants (attitude, self efficacy, intention), Blood lipids (total cholesterol, HDL-cholesterol, trigyceride), Blood pressure, Weight, Waist
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients are interviewed before and after the study. This will take about for hours of the patientsí time. The frequency of taking a venous blood sample and of the physical examinations is once every 3 three months and does not differ from the frequency in usual care.
The burden for patients from the intervention will be approximately 15 hours of extra education and time for counseling.
|- Main changes (audit trail)|
|- RECORD||20-sep-2007 - 12-mrt-2008|
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