Protocol for a randomised controlled trial to evaluate the effectiveness of the diabetes community exercise and education programme (DCEP) for long-term management of diabetes

Abstract

IntroductionType 2 diabetes is common in Māori and Pacific peoples and in those living in areas of high socioeconomic deprivation in New Zealand (NZ). People with type 2 diabetes often have multimorbidity, which makes their diabetes management more complex. The Diabetes Community Exercise and Education Programme (DCEP) is an interprofessional, patient-centred, whānau (family)-supported package of care specifically developed to engage with Māori and Pacific people and those living in deprived areas. We have previously demonstrated the feasibility and acceptability of the DCEP. This study aims to determine the effectiveness and cost-effectiveness of the DCEP through a pragmatic randomised controlled trial (RCT).Methods and analysis220 adults (age ≥35 years) with type 2 diabetes will be recruited from general practices in the lower South Island of NZ (Dunedin and Invercargill) to participate in an RCT. Participants will be randomised to intervention (DCEP) and control (usual care) groups. The DCEP participants will have their exercise goals agreed on with a physiotherapist and nurse and will attend two 90 min exercise and education sessions per week for 12 weeks. The primary outcome measure is blood glucose control (glycated haemoglobin). Secondary outcome measures include quality of life assessed using the Audit of Diabetes-Dependent Quality of Life questionnaire. Data will be collected at four time points: baseline, end of the 12-week intervention (3 months), 6 months postintervention (9 months) and 12 months after the intervention ends (15 months). We will also conduct a cost-effectiveness analysis and a qualitative process evaluation.Ethics and disseminationThe study has been approved by the Health and Disability Ethics Committee, Ministry of Health (HDEC17/CEN/241/AM01). A key output will be the development of an evidence-based training package to facilitate implementation of the DCEP in other NZ regions.Trial registration numberACTRN 12617001624370 p; Pre-results.

The diabetes community exercise programme plus usual care versus usual care in patients with type 2 diabetes: A randomised, two-arm, parallel, open-label trial

“…This study's protocol has been previously published 17 and only essential details from this are presented here along with information not provided in the protocol. The design was a two-arm, parallel group, open-label RCT conducted across two centres with blinding of the outcome assessor and data analyst to compare DCEP plus usual care with usual care alone.…”

“…This trial is registered with the Australian NZ Clinical Trials Registry (ANZCTR): ACTRN12617001624370p. The study protocol 17 can be found at http://dx.doi.org/10.1136/bmjopen- 2018–025,578.…”

“…As described previously 17 we recruited widely via general practices (GP), Diabetes NZ, public media advertising, and health agencies that work with Māori and Pacific communities. Potential participants were then formally referred to the study using the Electronic Referral Management System (ERMS, a GP electronic medical records referral system) via their GP or their health centre's practice nurse.…”

“…The programme has been described previously. 17 , 18 Its overarching aim is to support adults living with T2D to take control of their health and to live well with their long-term condition. It focuses on enhancing self-efficacy to engage in exercise and to do so long-term.…”

Assessment of medication adherence and quality of life among patients with type 2 diabetes mellitus in a tertiary hospital in Kelantan, Malaysia

“…Proper medication intake is vital in the management of T2DM which contributed to the therapeutic success (Marín-Peñalver et al, 2016). A positive impact on quality of life (QoL) as perceived by the patient is also a crucial criterion for evaluating the effectiveness of T2DM management (Hale et al, 2019). Adherence to drug treatment can be defined by the extent to which patients follow the instructions of their physician or other healthcare providers (Jimmy & Jose, 2011).…”