None listed
Conditions
Brief summary
Adherence to oral medication in Type 2 Diabetes is suboptimal. Patients reasons for non-adherence are multiple, and have been consistently demonstrated to be associated with patients’ beliefs about their illness and treatment (e.g., Horne et al., 2005). Patient beliefs about their illness and treatment are amenable to intervention (e.g., Clifford et al., 2006; Petrie et al., 2002; Petrie et al., 2012) and increasingly we are seeing the use of technology (e.g., SMS, internet, nurse-delivered tele-health) as a means of delivering healthcare interventions. The results from this study will allow us to determine whether technology can be used to improve medication adherence to oral medication for people living with Type 2 Diabetes in New Zealand. PHARMAC and the Ministry of Health will use the results of this study to guide policy. There are two key hypotheses in this study. 1. That people assigned to an intervention arm will achieve significantly greater medication adherence levels than control patients. 2. That people assigned to receive the most intensive level of intervention (e.g., SMS and web programme plus 5 phone calls) will achieve significantly greater medication adherence levels than patents assigned to lesser levels of intervention (e.g., SMS and web programme only, and SMS and web programme plus two phone calls). Five hundred and thirteen people prescribed oral medication for diabetes will be recruited from GP practices around New Zealand. They will be randomly allocated to three groups: low intervention, medium intervention and high intervention. The intervention will last six months, with a 12 month follow up. Participants will complete a questionnaire at baseline about their illness and treatment beliefs and this will be used to personalise the content they receive. Participants in all the groups receive personalised interventional text messages, emails and access to a website with diabetes specific information. Medium and high intervention streams receive interventional nurse phone calls at different frequencies. Data will be collected through self-report, and through mining of a public database of de-identified prescription redemption data. Participants will be invited to complete screening questions by telephone 3, 6 months, and 12 months after enrolling in the study. Prescription redemption data will be accessed for all enrolled participants 12 months after they enrol in the study. This data will assess their medication possession rates for the six months prior to intervention, and the 12 months following their enrolment. At this point a matched sample of 513 people will be identified to serve as a control. This de-identified data will be accessed from NZePS by the Ministry of Health and sent to PHARMAC. PHARMAC will compare the medications possession ratio data from the intervention study participants with the matched sample.
Interventions
High Intervention: Receives support in adherence to oral diabetes medication via telemedicine. Participants fill in an initial screener assessing thier beliefs about medicines, and illness representations. This information guides the selection of interventional content. Personalised texts and emails are written by a health psychologist. Interventional content is aimed towards supporting and encouraging adherence to oral medications for diabetes.
This group receives personalised text messages,
High Intervention: Receives support in adherence to oral diabetes medication via telemedicine. Participants fill in an initial screener assessing thier beliefs about medicines, and illness representations. This information guides the selection of interventional content. Personalised texts and emails are written by a health psychologist. Interventional content is aimed towards supporting and encouraging adherence to oral medications for diabetes. This group receives personalised text messages, emails and access to a website with 7 pages of information about diabetes, and using diabetes medication . They will received daily text messages plus emails twice a week for weeks 1-6. Then text mesages 3 times a week and email once a week for weeks 7-26. This intervention group also receives five 15-20 minute interventional phone calls from a registered nurse as per the below schedule. Day 1: Beliefs about Diabetes. Elicits discussion regarding illness representations for diabetes Day 10: Concerns about Diabetes Medication. Elicits discsussion regarding concerns about costs, side effects, addiction to medication and other potential concerns about medication Week 6: Elicits discussion and builds development of routines regarding organising and remembering Week 9: Elicits discussion around medication necessity Week 12: Elicits discussion around diabetes related distress. Medium Intervention: Receives support in adherence to oral diabetes medication via telemedicine. Participants fill in an initial screener assessing thier beliefs about medicines, and illness representations. This information guides the selection of interventional content. Personalised texts and emails are written by a health psychologist. Interventional content is aimed towards supporting and encouraging adherence to oral medications for diabetes. This group receives personalised text messages, emails and access to a website with 7 pages of information about diabetes, and using diabetes medication . They will receive daily text messages plus email twice a week for weeks 1-6. Then text mesages 3 times a week and email once a week for weeks 7-26. This intervention group also receives two 15-20 minute interventional phone calls from a registered nurse as per the below schedule. Day 1: Beliefs about Diabetes. Elicits discussion regarding illness representations for diabetes Day 10: Concerns about Diabetes Medication. Elicits discussion regarding concerns about costs, side effects, addiction to medication and other potential concerns about medication Low Intervention: Receives support in adherence to oral diabetes medication via telemedicine. Participants fill in an initial screener assessing thier beliefs about medicines, and illness representations. This information guides the selection of interventional content. Personalised texts and emails are written by a health psychologist. Interventional content is aimed towards supporting and encouraging adherence to oral medications for diabetes.. This group receives personalised text messages, emails andaccess to a website with 7 pages of information about diabetes, and using diabetes medication. They will receive daily text messages plus email twice a week for weeks 1-6. Then text mesages 3 times a week and email once a week for weeks 7-26. This group does not receive any interventional phone calls from the nurse. Examples of text messages: Participants receive text messages selected from a bank that are personally relevant to them according to thier initial screening questionnaire. Diabetes is always with you. But it doesn’t need to get in the way of your life. You can look after yourself by taking your medication every day. When taking your diabetes meds you may not feel any changes at all, especially if you felt fine before starting your medication. This is normal and common. Examples of emails: Participants receive emails selected from a bank that are personally relevant to them according to thier initial screening questionnaire. Example Email 1:If you find you are forgetting to take your medication, it’s a good idea to set up some systems to help you remember. Everyone is different, so what works for one person may not work for you. It may take a bit of practice before you find an approach that works for you. Read through the list below and think about whether any of these ideas might work for you. a. Keep your medication in sight. That way when you see your medication, you will be reminded to take it. b. Link taking your medication to something you do each day – like brushing your teeth or watching your favourite TV show. c. Set up reminders. You could set up an alarm on your mobile phone or write it on the calendar. d. You might find it helpful to carry some medicine with you each day. This will help you to take it when you need it. Find out more here – [insert link to Don’t forget!] Example email 2: Living with diabetes can feel overwhelming. You may have days when your diabetes makes you feel upset, worried or sad. It’s ok to feel this way. But don’t let these feelings get in the way of looking after yourself. Keep looking after yourself by taking your diabetes medication each day. In turn, you can feel better by knowing you are taking small steps to take control of your diabetes. Find out more here – [insert link to It’s ok to feel sad or mad about having diabetes]
Sponsors
Atlantis Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will be eligible to participate in this study if they have Type 2 diabetes for which they are prescribed oral medications only and are over 18. Participants who are prescribed insulin will be excluded from this study. Participants will be included in the study only if they have daily access to a mobile phone.
Exclusion criteria
Cannot read English. No Access to a mobile phone.
Outcome results
None listed