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Improving treatment adherence in people with diabetes mellitus

Towards the development of a personalised E-Health intervention for use in community pharmacies to analyse and improve medication non-adherence in people with type 2 diabetes mellitus, who are non-adherent to oral blood glucose and blood pressure lowering drugs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36009809
Enrollment
300
Registered
2020-02-05
Start date
2020-12-01
Completion date
Unknown
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus

Interventions

Current interventions as of 27/08/2020: This study will include people known to be not regularly taking their prescribed tablets or capsules for managing their type 2 diabetes. These p

Sponsors

University of East Anglia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. People with T2DM prescribed oral blood glucose lowering medication that are non-adherent to oral blood glucose and/or blood pressure lowering drugs 2. Aged 35-75 years 3. Smartphone user and willing to use platform facilities (digital health resources) or have access to an electronic device (e.g. computer) 4. All ethnicities 5. Able to understand text messages in English

Exclusion criteria

Exclusion criteria: 1. People with T2DM that use parenteral medication (e.g. insulin) for diabetes 2. People in which, according to screening data collected, adherence data is not valid due to hospital admission or in which medication is dispensed by different pharmacies 3. People who use medication-intake supporting services provided by the pharmacy (i.e. repeat dispensing and pill packaging) 4. People who indicate in the questionnaire that they suffer from the following major mental health disorders: depression, schizophrenia, psychosis or suicidality 5. Any significant medical reason for exclusion as determined by the researchers 6. Unable or not willing to provide written informed consent 7. Not willing to accept information transfer concerning participation in the study, and/or information regarding a participants’ health (like laboratory results or physical examination) and/or eventual adverse events to and from his GP and/or pharmacist 8. People who are involved in current research or have recently been involved in any research prior to recruitment

Design outcomes

Primary

MeasureTime frame
Medication adherence measured with a telephone pill count at baseline and the end of the trial (after 6 months)

Secondary

MeasureTime frame
1. Blood pressure measured by the GP at baseline, 3 and 6 months 2. HbA1c level measured by the GP at baseline, 3 and 6 months 3. Medication adherence measured using Medication Adherence Report Scale (MARS-5) questionnaire at baseline, 3 and 6 months 4. Attitude and beliefs toward medication measured using Beliefs about medicines questionnaire (BMQ specific questionnaire) at baseline, 3 and 6 months 5. Satisfaction with diabetes treatment measured using Diabetes Treatment Satisfaction Questionnaire (DTSQs+c) at baseline, 3 and 6 months 6. Quality of life measured using Quality of Life Questionnaire (EQ-5D-5L) at baseline, 3 and 6 months 7. Medical and productivity costs measured using Institute of Medical Technology Assessment (iMTA costs questionnaire) at 3 and 6 months

Countries

England, Netherlands, United Kingdom

Contacts

Public ContactDebi Bhattacharya
d.bhattacharya@leicester.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 13, 2026