Improving treatment adherence in people with diabetes mellitus

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN36009809
• Lead Sponsor: niversity of East Anglia

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36056388/ (added 05/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-05
• Study Completion: 2022-04-01
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 23

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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