Abstract Background: Antipsychotic-induced Weight Gain (AiWG) is a debilitating and common adverse effect of antipsychotics. AiWG negatively impacts life expectancy, quality of life, treatment adherence, likelihood of developing type-2 diabetes and readmission. Treatment of AiWG is currently challenging, and there is no consensus on the optimal management strategy. In this study, we aim to evaluate the use of metformin for the treatment of AiWG by comparing metformin with placebo in those receiving treatment as usual, which includes a lifestyle intervention. Methods: In this randomized, double-blind, multicenter, placebo-controlled, pragmatic trial with a follow-up of 52 weeks, we aim to include 256 overweight participants (Body Mass Index (BMI) > 25 kg/m2) of at least 16years of age. Patients are eligible if they have been diagnosed with schizophrenia spectrum disorder and if they have been using an antipsychotic for at least three months. Participants will be randomized with a 1:1 allocation to placebo or metformin, and will be treated for a total of 26 weeks. Metformin will be started at 500 mg b.i.d. and escalated to 1000 mg b.i.d. 2 weeks thereafter (up to a maximum of 2000mg daily). In addition, all participants will undergo a lifestyle intervention as part of the usual treatment consisting of a combination of an exercise program and dietary consultations. The primary outcome measure is difference in body weight as a continuous trait between the two arms from treatment inception until 26 weeks of treatment, compared to baseline. Secondary outcome measures include: 1) Any element of metabolic syndrome (MetS); 2) Response, defined as ≥5% body weight loss at 26 weeks relative to treatment inception; 3) Quality of life; 4) General mental and physical health; and 5) Cost-effectiveness. Finally, we aim to assess whether genetic liability to BMI and MetS may help estimate the amount of weight reduction following initiation of metformin treatment. Discussion: The pragmatic design of the current trial allows for a comparison of the efficacy and safety of metformin in combination with a lifestyle intervention in the treatment of AiWG, facilitating the development of guidelines on the interventions for this major health problem.
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BACKGROUND: Paratonia, a form of hypertonia, is associated with loss of mobility and with the development of contractures especially in the late stages of the dementia. Passive movement therapy (PMT) currently is the main physiotherapeutic intervention. General doubt about the beneficial effects of this widely used therapy necessitates a randomised clinical trial (RCT) to study the efficacy of PMT on the severity of paratonia and on the improvement of daily care.METHODS/DESIGN: A RCT with a 4-week follow-up period. Patients with dementia (according to the DSM-IV-TR Criteria) and moderate to severe paratonia are included in the study after proxy consent. By means of computerised and concealed block randomisation (block-size of 4) patients are included in one of two groups. The first group receives PMT, the second group receives usual care without PMT. PMT is given according to a protocol by physical therapist three times a week for four weeks in a row. The severity of paratonia (Modified Ashworth scale), the severity of the dementia (Global Deterioration Scale), the clinical improvement (Clinical Global Impressions), the difficulty in daily care (Patient Specific Complaints) and the experienced pain in daily care of the participant (PACSLAC-D) is assessed by assessors blind to treatment allocation at baseline, after 6 and 12 treatments. Success of the intervention is defined as a significant increase of decline on the modified Ashworth scale. The 'proportion of change' in two and four weeks time on this scale will be analysed. Also a multiple logistic regression analysis using declined/not declined criteria as dependent variable with correction for relevant confounders (e.g. stage of dementia, medication, co-morbidity) will be used.DISCUSSION: This study is the first RCT of this size to gain further insight on the effect of passive movement therapy on the severity of paratonia.TRIAL REGISTRATION: Current Controlled Trials ISRCTN43069940.
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ABSTRACT Background: We investigated if the addition of an inter-professional student-led medication review team (ISP-team) to standard care can increase the number of detected ADRs and reduce the number of ADRs 3 months after an outpatient visit. Research design and methods: In this controlled clinical trial, patients were allocated to standard care (control group) or standard care plus the ISP team (intervention group). The ISP team consisted of medical and pharmacy students and student nurse practitioners. The team performed a structured medication review and adjusted medication to reduce the number of ADRs. Three months after the outpatient visit, a clinical pharmacologist who was blinded for allocation performed a follow-up telephone interview to determine whether patients experienced ADRs. Results: During the outpatient clinic visit, significantly more (p < 0.001) ADRs were detected in the intervention group (n = 48) than in the control group (n = 10). In both groups, 60–63% of all detected ADRs were managed. Three months after the outpatient visit, significantly fewer (predominantly mild and moderately severe) ADRs related to benzodiazepine derivatives and antihypertensive causing dizziness were detected in the patients of the intervention group. Conclusions: An ISP team in addition to standard care increases the detection and management of ADRs in elderly patients resulting in fewer mild and moderately severe ADRs
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De mondgezondheid van te veel jonge kinderen in Nederland is slecht: tandbederf (cariës) komt vaak voor. Een deel van de kinderen bezoekt de mondzorgprofessional te laat. Om de mondgezondheid van deze kinderen te verbeteren is de interventie Gezonde Peutermonden ontwikkeld. Op consultatiebureaus zorgt een mondzorgcoach (mondzorgprofessional) voor coaching en begeleiding van ouders van jonge kinderen bij het aanleren van gezonde eet-/ en mondzorg gedrag. Het effect hiervan wordt momenteel in een 'clinical trial' getest. De tussentijdse resultaten zijn veelbelovend en de interventie heeft enthousiaste reacties opgeleverd. Terwijl een definitieve trialuitkomst op zich laat wachten, nemen mondzorgpraktijken het initiatief tot samenwerking met Jeugdgezondheidszorg. In de regio Heerlen en Tilburg is vanwege een hoog percentage van kinderen met tandbederf, grote belangstelling en bereidheid van mondzorgprofessionals, gemeente, GGD en zorgverzekeraar om het initiatief te nemen. Zij vragen ons om hulp en ondersteuning bij interventie implementatie in hun regio. Naar aanleiding hiervan willen wij in samenwerking met deze partijen in beide regio’s de implementatie van Gezonde Peutermonden onderzoeken. Het doel daarbij is het krijgen van inzicht in de belemmerende en bevorderende factoren bij de implementatie van Gezonde Peutermonden. Zodoende wordt beoogd de ‘beste’ implementatiestrategieën te kunnen achterhalen. Door het verzamelen van kwantitatieve en kwalitatieve gegevens middels ‘mixed methods’ wordt de context in kaart gebracht, gericht op factoren binnen en buiten de organisatie, kenmerken van de doelgroep en de zorgverleners. Scholing, een ‘toolkit’ en voorlichtingsmateriaal worden ontwikkeld en beschikbaar gesteld aan mondzorgprofessionals. Proces-en effectuitkomsten worden gemeten, waartoe gegevens worden verzameld voor, tijdens en na de implementatie van de interventie. Deze aanvraag beschrijft de extra inspanning om de interventie Gezonde Peutermonden om te zetten naar een blended vorm, combinatie van fysieke en video/telefonische consulten, en de ontwikkeling van een protocol voor de gecombineerde consulten voor kinderen tussen 0-4 jaar ten gevolge van de Covid-19 maatregelen.
