ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001305415

Ethics application status

Approved

Date submitted

9/09/2016

Date registered

19/09/2016

Date last updated

19/09/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

MyMeds: A pilot study assessing the impact of technology in delivering personalised interventions to support patients to adhere to oral anti-diabetic medication

Scientific title

MyMeds: A pilot study assessing the impact of technology in delivering personalised interventions to support patients to adhere to oral anti-diabetic medication

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

U1111-1187-1476

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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]

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Intervention code [3]

Treatment: Devices

Comparator / control treatment

Control: Non-randomised matched sample will serve as a control. This group will receive no intervention. The only data which will be extracted on this control group will be thier prescription redemption rates.

Control group

Active

Outcomes

Primary outcome [1]

Adherence to oral diabetes medication measured by prescription redemption rate for oral diabetes medication.

Timepoint [1]

This outcome will be assessed at 3, 6 and 12 months after the trial commences.

Secondary outcome [1]

Self report non-intentional non-adherence to oral diabetes medication. Measured by the item
How often do you forget to take your diabetes medication?
Likert scale Never, Rarely, Sometimes, Often, Always.

Timepoint [1]

This outcome will be assessed at 3, 6 and 12 months after the trial commences.

Secondary outcome [2]

Self report intentional non-adherence to diabtetes medication measured by: How often do you choose not to take your diabtetes medication. Likert scale Never, Rarely, Sometimes, Often, Always.

Timepoint [2]

This outcome will be assessed at 3, 6 and 12 months after the trial commences.

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Cannot read English. No Access to a mobile phone.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomised table created by computer software.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Power Calculation
To estimate an adequate sample size, a power calculation was conducted. The effect size was based on data from two research papers exploring adherence in diabetes. Vervloet and collegues (2012) demonstrated that mean adherence (measured with electronic monitoring device) was 10.3% higher in the group receiving text reminders and those in the control group. The standard deviation of prescription redemption data was likely to be higher than that of the electronic monitoring device data, therefore the standard deviation of the sample was estimated from Wilke et al (2016). In this study Medications Prescription redemption data was used to calculate adherence to diabetes medications across a range of international research sites revealing an average standard deviation of 29.9%. Using a significant level of p<.05 with a two tailed test and an 80% probability of detecting an effect, these figures give an effect size of 0.34 and a final sample size required per group of 134. Once we include the attrition rate of 30% that gives a sample size required per group of 171 and a total sample of 1026 for the three intervention groups and the matched sample which will form the control group.
Data analysis
Data will be analysed using SPSS. Data will be collated on an intention to treat basis. Data will be cleaned according to best practice principles, as follows. Data will be entered into an SPSS data file and then subjected to a cleaning procedure to identify mis-entered variables. This involves scanning frequency tables and removing mis-entered data.
Missing data will be accounted for using two procedures reported by Byrne (2001), list wise deletion and pattern matching imputation.
Participants with missing data (and those who withdraw during the course of the study) will be compared with the final sample to assess if they differ significantly on any demographic or baselines measures. These results will be reported.
Data will be checked for normality. A mixed between and within ANOVA (or its non-parametric equivalent) will be used to explore the hypotheses, comparing change in adherence levels between groups. This will account for any differences present between groups at baseline.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

10/03/2016

Date of last participant enrolment

Anticipated

30/11/2016

Actual

Date of last data collection

Anticipated

30/11/2017

Actual

Sample size

Target

1026

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

PHARMAC

Address [1]

PO Box 10254
Wellington 6143

Country [1]

New Zealand

Primary sponsor type

Commercial sector/Industry

Name

Atlantis Healthcare

Address

PO Box 37012
Parnell
Auckland 1151

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability Ethics Commitee

Ethics committee address [1]

PO BOx 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

30/06/2016

Approval date [1]

25/08/2016

Ethics approval number [1]

16/NTA/99

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Reasons for delay in completing formal ethics approval for the study. 
Both Atlantis Healthcare and PHARMAC (study sponsor) were unclear at the outset of study design whether formal ethics committee approval was necessary for the study. Part-way through the enrolment process we re-visited this issue and decided that it was necessary to acquire formal approval. This was done, with enrolment into the study being paused until full approval was received from the Health and Disability Ethics Committee (HDEC). In hindsight we acknowledge that we should have acquired ethics committee approval during the study design phase, before implementation began. 

HDEC approved a process to allow patients who were already enrolled in the study the opportunity to give their informed consent to the study and continue following ethics committee approval. Patients were given three options:

To consent to continue to receive interventional content AND remain as part of the study group; OR   
To consent to continue to receive interventional content but not remain as part of the study group: OR
Decline receiving further interventional content AND decline to be part of the study group.

Our study nurses contacted patients to outline the situation re ethics approval and offer the above options. All but one of the contacted participants have decided to consent to continue on the programme and the study, Only one person has declined to be part of the study, but wanted to continue to receive the interventional content. This patient has now been removed from the study sample.

Contacts

Principal investigator

Name

Dr Jodie Main

Address

Atlantis Healthcare, PO Box 37012, Parnell, Auckland 1151,

Country

New Zealand

Phone

+64274034785

Fax

jodie.main@atlantishealthcare.com

Contact person for public queries

Name

Andrew Beszant

Address

Atlantis Healthcare, PO Box 37012, Parnell, Auckland 1151,

Country

New Zealand

Phone

+64212753555

Fax

andrew.beszant@atlantishealthcare.com

Contact person for scientific queries

Name

Jodie Main

Address

Atlantis Healthcare, PO Box 37012, Parnell, Auckland 1151,

Country

New Zealand

Phone

+64274034785

Fax

jodie.main@atlantishealthcare.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No additional documents have been identified.

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