It is hypothesised that this study leads to a personalised intervention program that improves medication adherence in people with type 2 diabetes mellitus that are non-adherent to their oral blood glucose lowering and/or antihypertensive medication.
ID
Bron
Verkorte titel
Aandoening
Type 2 diabetes mellitus, medication non-adherence
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure of the study is medication adherence measured with a telephone pillcount. The pillcount will be conducted at baseline and after six months.
Achtergrond van het onderzoek
Medication non-adherence is a prevalent health problem in people with type 2 diabetes mellitus. Multiple interventions have previously been developed to enhance medication adherence. However, very few studies demonstrated an improvement of treatment outcomes and even the most efficacious interventions only achieved modest effect sizes. An explanation for these moderate effects can be that interventions are not tailored to the needs and preferences of individual patients.
Therefore, the aim of this study is to develop and test a personalised intervention to improve medication adherence in people with T2DM, who are non-adherent to oral blood glucose and/or blood pressure lowering drugs. This will be tested in a parallel-group randomised controlled trial that will be conducted in 40-50 (community) pharmacies and adjoining practises in the Netherlands and the United Kingdom (UK). A total of 300 participants will be included (150 the Netherlands / 150 the UK) and the follow-up period of the trial will be six months.
The intervention condition is a personalised intervention program that is based on one or more of the participants’ predefined non-adherence profile(s). The supporting program will be tailored to a participants’ specific situation, needs and preferences. Participants that are assigned to the control condition will receive access to a publicly available general T2DM information platform.
The primary outcome is medication adherence measured with a telephone pillcount. Secondary outcome measures are systolic blood pressure, HbA1c, self-reported medication adherence, attitude and beliefs toward medication, satisfaction with diabetes treatment, quality of life, and medical and productivity costs.
Doel van het onderzoek
It is hypothesised that this study leads to a personalised intervention program that improves medication adherence in people with type 2 diabetes mellitus that are non-adherent to their oral blood glucose lowering and/or antihypertensive medication.
Onderzoeksopzet
Measurements at baseline, after 3 months and after 6 months
Onderzoeksproduct en/of interventie
The intervention condition is a personalised intervention program that is based on one or more of the participants’ predefined non-adherence profile(s). The four non-adherence profile(s) are: (I) knowledge and perceptions, (II) practical problems, (III) side effects, and (IV) negative mood and beliefs. The supporting program will be tailored to a participants’ specific situation, needs and preferences. Participants that are assigned to the control condition will receive access to a publicly available general T2DM information platform.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
The main inclusion criteria are:
1) People with type 2 diabetes mellitus treated with oral blood glucose lowering drugs;
2) Non-adherent to oral blood glucose and/or blood pressure lowering drugs;
3) Aged 35-75 years;
4) Mobile phone user.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
The main exclusion criteria are:
1) Use of insulin;
2) People that use medication-intake supporting services provided by the pharmacy;
3) People that suffer from major psychiatric disorders;
4) People that are ‘starters’, meaning that they started using the medicine somewhere in the period in which the dispensing score was calculated;
5) People that are ‘stoppers’, meaning that they did not have a medicine dispatch in the last four months of the period in which the dispensing score was calculated.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8747 |
| Ander register | METC Amsterdam UMC, location VUmc : 2018.160 |