Project Trial: Enhancing Type 2 Diabetes treatment through digital plans of care
This project will look at how a personalised experience, delivered through a mobile and web app can improve lifestyle and behavioural outcomes for patients living with Type-2 Diabetes. It will address the opportunity to reduce the costs of delivering care plans of information, structured education, diet and lifestyle advice and local services through digital tools. In addition, we will explore how the mobile app and the platform it is built upon, can provide actionable insights and shared decision making tools that enable practitioners across the whole care pathway to deliver better outcomes and joined up care. The project will consider the user experience (both staff and participant) as this is key to providing insight and outcomes.
Healum Ltd (digital health tech lead)
Vernova CIC Foundation
Centre for Primary Care at Manchester University (Patient Outcomes Evaluator)
Diabetes UK (Diabetes Consultant)
Research Title: A Randomised control pilot study to explore the impact and efficacy of the Healum Collaborative Care planning Software and App on condition management in the Type 2 Diabetes Mellitus Population in NHS Primary Care
Planned sample size: 216 control, 216 variable
Treatment duration: 6 months
A randomised controlled pilot trial with active variable groups and control groups will be undertaken with the intention of gathering preliminary data on the intervention that will inform a longer RCT with a higher power calculation. We will have an anonymised control group of 216 participants and data will be consented and pulled from Practice records. We will use the following framework:
(i) Control Group: The control group will be made up of 216 patients with Type 2 Diabetes that receive the usual standard of care. Anonymized data will be pulled from the data held by the surgery.
(ii) Variable Group: 216 patients will have access to the Healum app and will receive content from an HCP once per week through the app. Variable group will have visits and be checked for the same measures at 0 and 6 months with a nurse or GP.
Participants identified suitable for the variable group will be contacted and asked if they are keen to participate in the study. This recruitment can be done opportunistically through direct contact with the patient at the surgery or through a mailout for those patients who are coming for their regular review in the coming months. Ahead of their review, the participant will be provided a Participant Information Sheet and Consent Form which they will read, have the opportunity to ask questions about and sign virtually. This allows us to run the trial and gather learnings with as much of the burden resting on digital tools as possible, instead of on human resource, ultimately improving the scalability of the digital platform and reducing the burden on NHS resources.
Upon beginning participants will provide demographic data via their app. This demographic data will be coded to unique participant IDs and patient direct identifiable information will be removed (name, phone number, email, month and day of birth, and address; first three characters of postcode will remain in order to allow us to use the Index of Multiple Deprivation). All information that would link unique IDs to patient identifiable information will be held securely be Healum.
Software and App Set-up and Training
Software and app set up and training will be done by Healum with practice staff and participants. This will be done with face-to-face training, support videos and FAQs, local experts and Healum floor walkers.
Patients who meet our inclusion and exclusion criteria will be identified through the practice’s EHR. We will then approach those whose 6-month bi-annual review is approaching as to not interrupt standard of care. We will contact these patients when the are contacted to come in for their review using the mechanism the surgery has in place (email, text, post, phone call). We will also place a web link on the practice’s website and place leaflets in the surgery. We will provide clinicians with leaflets so that they can pass them to patients that might be eligible and approaching their review.
Q1: Are the practices paid to participate in the research?
A1: Yes, practices are paid as per the NIHR costing template
Q2: How will patient consent be taken?
A2: Refer to point Consenting paragraph above
Q3: Can we know more about IG and security?
A3: You can read the Healum IG policy here
Q4: Does everyone from the practice need to participate?
A4: No, only the Diabetes MDT needs to participate, which would include, Practice Nurse, Diabetes care team, GP, Research lead etc.
Q5: What is the patient inclusion criteria for research recruitment?
A5: Participants who are:
● capable of reading the PIS and giving informed consent themselves
● over the age of 18
● living with Type 2 Diabetes Mellitus
● have a smartphone and are able to use 3 apps that are not categorised as Utilities (ie. clock, calculator, phone, etc)
● with an HbA1c of over 65 mmol/mol
Please feel free to reach out to us at [email protected] with any project related queries.