Evidence map›Paper›PMID 36056388›Full record

ArticleTrials2022

A personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with type 2 diabetes mellitus, the INTENSE study: study protocol for a randomised controlled trial.

Marlous Langendoen-Gort, Hiyam Al-Jabr, Jacqueline G Hugtenburg, Femke Rutters, Maartje de Wit, Debi Bhattacharya, Ameen Abu-Hanna, Andrew Farmer, Petra J M Elders

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 43% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 2 countries.

Marlous Langendoen-GortAmsterdam UMC location Vrije Universiteit Amsterdam, Department of General Practice, Boelelaan 1117, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0001-5098-6128
Hiyam Al-JabrIntegrated Care Academy, University of Suffolk, Ipswich, UK.
Jacqueline G HugtenburgAmsterdam Public Health Research Institute, Amsterdam, The Netherlands.
Femke RuttersAmsterdam Public Health Research Institute, Amsterdam, The Netherlands.
Maartje de WitAmsterdam Public Health Research Institute, Amsterdam, The Netherlands.
Debi BhattacharyaSchool of Allied Health Professions, University of Leicester, United Kingdom School of Pharmacy, University of East Anglia, Norwich, UK.
Ameen Abu-HannaAmsterdam Public Health Research Institute, Amsterdam, The Netherlands.
Andrew FarmerNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Petra J M EldersAmsterdam UMC location Vrije Universiteit Amsterdam, Department of General Practice, Boelelaan 1117, Amsterdam, The Netherlands. p.elders@amsterdamumc.nl.
Amsterdam University Medical Centers · NLAmsterdam Neuroscience · NLUniversity of East Anglia · GBUniversity of Oxford · GBUniversity of Suffolk · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMedication non-adherence is a prevalent health problem in people with type 2 diabetes mellitus (T2DM). Interventions have previously been developed to improve medication adherence, but inconsistent outcomes have been reported. A potential explanation for this inconsistency is a 'one size fits all' approach, with interventions not tailored to the needs and preferences of individuals. Therefore, the aim of this study is to evaluate the effectiveness of a personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with T2DM.

methodsA parallel-group randomised controlled trial will be conducted in 40-50 community pharmacies in the Netherlands and the United Kingdom (UK). A total of 300 participants will be included and followed up for a period of 6 months. Participants will be people with T2DM identified as non-adherent to oral antidiabetic and/or antihypertensive medication, aged 35-75 years and mobile phone users. The intervention group will receive a personalised intervention programme that is based on one or more of the participants' pre-defined non-adherence profile(s), namely (I) Knowledge and perceptions, (II) Practical problems, (III) Side effects and (IV) Negative mood and beliefs. The intervention comprises of one or more supporting modules, namely (I) Brief messaging, (II) Clinical medication review, (III) Medication schedule, (IV) Reminding messaging, (V) Medication dispensing systems, (VI) Smart messaging, (VII) Referral to general practitioner and (VIII) Unguided web-based Self Help Application for low mood. The control group will receive usual care including access to a publicly available informative diabetes website. The primary study outcome is medication adherence measured with a telephone pill count. Secondary outcomes are systolic blood pressure, HbA1c level, self-reported medication adherence, attitude and beliefs toward medication, satisfaction with diabetes treatment, health status and medical consumption and productivity cost. In addition, a process evaluation will be undertaken to establish the fidelity, reach and the extent to which intervention delivery is normalised in the daily practice of community pharmacy teams. DISCUSSION: The study can lead to a personalised intervention programme that improves medication adherence in people with T2DM that are non-adherent to oral antidiabetic and/or antihypertensive medication.

trial registrationDutch Trial Register, Trial NL8747 , registered 02 July, 2020; ISRCTN Registry, ISRCTN36009809 , registered 05 February, 2020.

Indexed as

Antihypertensive AgentsDiabetes Mellitus, Type 2Hypoglycemic AgentsMedication AdherenceAdultAgedCounselingHumansMiddle AgedRandomized Controlled Trials as TopicAntihypertensive AgentsHypoglycemic AgentsMedication adherencePersonalised intervention programmePharmacyType 2 diabetes mellitus

Identifiers

PMID36056388
PMCPMC9438235
OpenAlexW4294219245

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.