PMID- 36056388 OWN - NLM STAT- MEDLINE DCOM- 20220907 LR - 20220909 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 23 IP - 1 DP - 2022 Sep 2 TI - 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. PG - 731 LID - 10.1186/s13063-022-06491-7 [doi] LID - 731 AB - BACKGROUND: Medication 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. METHODS: A 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 REGISTRATION: Dutch Trial Register, Trial NL8747 , registered 02 July, 2020; ISRCTN Registry, ISRCTN36009809 , registered 05 February, 2020. CI - (c) 2022. The Author(s). FAU - Langendoen-Gort, Marlous AU - Langendoen-Gort M AUID- ORCID: 0000-0001-5098-6128 AD - Amsterdam UMC location Vrije Universiteit Amsterdam, Department of General Practice, Boelelaan 1117, Amsterdam, The Netherlands. AD - Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. FAU - Al-Jabr, Hiyam AU - Al-Jabr H AD - Integrated Care Academy, University of Suffolk, Ipswich, UK. FAU - Hugtenburg, Jacqueline G AU - Hugtenburg JG AD - Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. AD - Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Clinical Pharmacology and Pharmacy, Boelelaan 1117, Amsterdam, The Netherlands. FAU - Rutters, Femke AU - Rutters F AD - Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. AD - Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Epidemiology and Data Science, Boelelaan 1117, Amsterdam, The Netherlands. FAU - de Wit, Maartje AU - de Wit M AD - Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. AD - Amsterdam UMC location Vrije Universiteit Amsterdam, Department of Medical Psychology, Boelelaan 1117, Amsterdam, The Netherlands. FAU - Bhattacharya, Debi AU - Bhattacharya D AD - School of Allied Health Professions, University of Leicester, United Kingdom School of Pharmacy, University of East Anglia, Norwich, UK. FAU - Abu-Hanna, Ameen AU - Abu-Hanna A AD - Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. AD - Amsterdam UMC location University of Amsterdam, Department of Medical Informatics, Meibergdreef 9, Amsterdam, The Netherlands. FAU - Farmer, Andrew AU - Farmer A AD - Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. FAU - Elders, Petra J M AU - Elders PJM AD - Amsterdam UMC location Vrije Universiteit Amsterdam, Department of General Practice, Boelelaan 1117, Amsterdam, The Netherlands. p.elders@amsterdamumc.nl. AD - Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. p.elders@amsterdamumc.nl. LA - eng PT - Clinical Trial Protocol PT - Journal Article DEP - 20220902 PL - England TA - Trials JT - Trials JID - 101263253 RN - 0 (Antihypertensive Agents) RN - 0 (Hypoglycemic Agents) SB - IM MH - Adult MH - Aged MH - *Antihypertensive Agents/therapeutic use MH - Counseling MH - *Diabetes Mellitus, Type 2/drug therapy MH - Humans MH - *Hypoglycemic Agents/therapeutic use MH - *Medication Adherence MH - Middle Aged MH - Randomized Controlled Trials as Topic PMC - PMC9438235 OTO - NOTNLM OT - Medication adherence OT - Personalised intervention programme OT - Pharmacy OT - Type 2 diabetes mellitus COIS- The authors declare that they have no competing interests. EDAT- 2022/09/03 06:00 MHDA- 2022/09/08 06:00 PMCR- 2022/09/02 CRDT- 2022/09/02 23:46 PHST- 2021/12/24 00:00 [received] PHST- 2022/06/21 00:00 [accepted] PHST- 2022/09/02 23:46 [entrez] PHST- 2022/09/03 06:00 [pubmed] PHST- 2022/09/08 06:00 [medline] PHST- 2022/09/02 00:00 [pmc-release] AID - 10.1186/s13063-022-06491-7 [pii] AID - 6491 [pii] AID - 10.1186/s13063-022-06491-7 [doi] PST - epublish SO - Trials. 2022 Sep 2;23(1):731. doi: 10.1186/s13063-022-06491-7.