Diabetes Care Protocol: effects on patient-important outcomes. A cluster randomized, non-inferiority trial in primary care

Autor: G. E. H. M. Rutten, M. H. Minkman, M. van den Donk, Frits G.W. Cleveringa, Kees J. Gorter
Jazyk: angličtina
Rok vydání: 2010
Předmět:
Male
Pediatrics
medicine.medical_specialty
Visual analogue scale
Endocrinology
Diabetes and Metabolism
Health Status
Type 2 diabetes
Medical sciences
law.invention
Endocrinology
Quality of life (healthcare)
Patient satisfaction
Randomized controlled trial
Clinical Protocols
law
Surveys and Questionnaires
Outcome Assessment
Health Care
Internal Medicine
medicine
Cluster Analysis
Humans
Bescherming en bevordering van de menselijke gezondheid
Geneeskunde(GENK)
Aged
Netherlands
Econometric and Statistical Methods: General
Primary Health Care
business.industry
Geneeskunde (GENK)
Middle Aged
medicine.disease
Decision Support Systems
Clinical
Obesity
General [Econometric and Statistical Methods]
Self Efficacy
Clinical trial
Diabetes Mellitus
Type 2
Patient Satisfaction
Physical therapy
Female
business
Psychosocial
Zdroj: Diabetic Medicine, 27(4), 442. Wiley-Blackwell
ISSN: 0742-3071
Popis: Aims The Diabetes Care Protocol (DCP) combines task delegation, intensification of diabetes treatment and feedback. It reduces cardiovascular risk in Type 2 diabetes (T2DM) patients. This study determines the effects of DCP on patient-important outcomes. Methods A cluster randomized, non-inferiority trial, by self-administered questionnaires in 55 Dutch primary care practices: 26 practices DCP (1699 patients), 26 usual care (1692 patients). T2DM patients treated by their general practitioner were included. Main outcome was the 1-year between-group difference in Diabetes Health Profile (DHP-18) total score. Secondary outcomes DHP-18 subscales, general perceived health [Medical Outcomes Study 36-Items Short Form Health Survey (SF-36), Euroqol 5 Dimensions (EQ-5D) and Euroqol visual analogue scale (EQ-VAS)], treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire; DTSQ status) and psychosocial self-efficacy (Diabetes Empowerment Scale Short Form; DES-SF). Per protocol (PP) and intention-to-treat (ITT) analyses were performed: non-inferiority margin Delta=-2%. At baseline 2333 questionnaires were returned and 1437 1 year thereafter. Results Comparing DCP with usual care, DHP-18 total score was non-inferior: PP -0.88 (95% CI -1.94 to 0.12), ITT -0.439 (95% CI -1.01 to 0.08), SF-36 'health change' improved: PP 3.51 (95% CI 1.23 to 5.82), ITT 1.91 (95% CI 0.62 to 3.23), SF-36 'social functioning' was inconclusive: PP-1.57 (95% CI-4.3 to 0.72), ITT-1.031 (95% CI-2.52 to -0.25). Other DHP and SF-36 scores were inconsistent or non-inferior. DHP-18 'disinhibited eating' was significantly worse in PP analyses. For EQ-5D/EQ-VAS, DTSQ and DES-SF, no significant between-group differences were found. Conclusion DCP does not seem to influence health status negatively, therefore diabetes care providers should not shrink from intensified treatment. However, they should take possible detrimental effects on 'social functioning' and 'disinhibited eating' into account.
Databáze: OpenAIRE
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