Improving treatment adherence in people with diabetes mellitus-INTENSE
Research type
Research Study
Full title
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/or blood pressure lowering drugs.
IRAS ID
262822
Contact name
Debi Bhattacharya
Contact email
Sponsor organisation
University of East Anglia
Duration of Study in the UK
1 years, 10 months, 30 days
Research summary
The population with diabetes mellitus will continue to increase in the future according to the International Diabetes Federation. People with type 2 diabetes mellitus (T2DM) have an increased risk of developing long-term complications. Besides lifestyle recommendations, people with diabetes are treated with oral blood glucose lowering drugs, insulin and/or other medications. Given medications target controlling blood glucose levels and decreasing the risk of disease-related complications.
However, literature reports that medication adherence is suboptimal in 10 to 56% of all people with type 2 diabetes mellitus (T2DM). This non-adherence leads to suboptimal control of diabetes and is associated with increased hospitalisations, mortality rates and health care costs. Despite numerous adherence interventions reported, few demonstrate an improvement in treatment outcomes. This may be due to lack of tailoring the intervention to the needs and preferences of individual patients.
Since the burden of medication non-adherence in T2DM is a complex and global problem, interventions aimed to reduce non-adherence should be designed in such a manner that they can be applied in different settings and adapted to real-world conditions. In addition, resources required to implement such interventions should be considered and be made available at low costs. Interventions that use digital health resources (e.g. mobile phone support) are promising with regard to reach and affordability, but evidence on their efficacy is still limited.
Therefore, the aim of this trial is to develop and investigate the (cost-) effectiveness of a personalised intervention program to improve medication adherence in people with T2DM who are non-adherent to oral blood glucose and/or blood pressure lowering medicines. The intervention group will receive a personalised intervention program selected based on their non-adherence profile. The control group will receive usual care combined with access to an already available general T2DM information website.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0407
Date of REC Opinion
2 Jul 2019
REC opinion
Unfavourable Opinion