Condition category
Nutritional, Metabolic, Endocrine
Date applied
07/08/2017
Date assigned
08/08/2017
Last edited
09/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
More than 11 million people in England have type 2 diabetes or hypertension (high blood pressure). Taking medication as prescribed can significantly reduce risks, complications and early deaths associated with these conditions, but many people with these conditions do not take their medication as prescribed. GPs and nurses can support patients in taking their medication but they have limited time. There is therefore a need for low-cost solutions for helping patients to take their medication as prescribed. A promising approach is to use automated telephone interventions. Text and voice messages sent to patients’ mobile phones and landlines can deliver personalised and tailored support over a period of time. The aim of this study is to find out whether the use of text and voice messages is feasible and acceptable to patients and whether it helps patients take their medication as prescribed.

Who can participate?
Patients aged 18 or over with type 2 diabetes or high blood pressure from six general practices

What does the study involve?
Participants are randomly allocated to the intervention or control group. The intervention group receive usual care plus interactive text and voice messages to promote medication adherence. The comparator group receive usual care only. The study lasts for 3 months and both groups’ medication adherence, blood pressure and blood sugar levels are measured at the end of the study.

What are the possible benefits and risks of participating?
If the results are encouraging, the text and voice messages will be tested in a large study. The study may benefit patients by supporting them to take their medications as prescribed and improving their health. This would also benefit the NHS by reducing hospital admissions, additional consultations, referrals and investigations, and medicine wastage. The risk of side effects is generally very low.

Where is the study run from?
University of Cambridge (UK)

When is the study starting and how long is it expected to run for?
December 2014 to December 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Katerina Kassavou
kk532@medschl.cam.ac.uk

Trial website

http://www.phpc.cam.ac.uk/pcu/research/research-projects-list/other-projects/maps/

Contact information

Type

Public

Primary contact

Dr Katerina Kassavou

ORCID ID

Contact details

University of Cambridge
Department of Public Health and Primary Care
PCU
Cambridge
CB2 0SR
United Kingdom
+44 (0)1223 330 456
kk532@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34706

Study information

Scientific title

Feasibility of MAPS (Medication Adherence for Patient Support): a highly tailored text and voice messaging intervention to support medication adherence among patients with type 2 diabetes and/or hypertension in primary care

Acronym

MAPS

Study hypothesis

This study aims to develop and assess the feasibility of MAPS: a highly tailored interactive text (SMS) and voice (IVR) intervention to promote medication adherence in patients with hypertension and/or type 2 diabetes, in primary care. The objectives are to develop the intervention, finalise the design of the study, and assess the feasibility, acceptability, cost and potential efficacy of the intervention.

Ethics approval

East of England Essex Research Ethics Committee, 25/05/2017, ref: 17/EE/0203

Study design

Randomised; Both; Design type: Process of Care, Education or Self-Management, Psychological & Behavioural, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Primary Care, Primary sub-specialty: Diabetes; UKCRC code/ Disease: Cardiovascular/ Hypertensive diseases, Metabolic and Endocrine/ Diabetes mellitus

Intervention

Participants will be randomised to the intervention (N=60) or comparator (n=40) group stratified by age, gender, practice and disease condition using a secure, computer random number generator:
1. The intervention group will receive usual care plus interactive text (SMS) and voice (IVR) message intervention aiming to promote medication adherence
2. The comparator group will receive usual care only

Using unequal group sizes will increase the information obtained about participants’ use of and response to the intervention. Randomisation will be conducted independently of the study co-ordination and intervention, with blinding of access to further participant information. If more than one member of the same household is included, they will be randomised to the same arm. Contamination between groups will be assessed by asking participants whether they know anyone else who is participating and which group they are in. Treatment duration will be 3 months for both intervention and comparator group. Follow up data will be collected at the end of the intervention (i.e., 3 months).

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Medication adherence:
1.1. Self-reported medication adherence, measured using two items at baseline and 3 months
1.2. Objectively measured medication adherence, collected by electronic monitoring devices (MEMS container caps that record the date and time of each opening) at 3 months
1.3. Objectively measured refill medication data, collected using records from practice or pharmacy dispensary at baseline and 3 months
2. Blood pressure, collected using an electronic sphygmomanometer or other blood pressure monitor devices available in each practice at 3 months
3. Glucose levels (HbA1c), collected using venous blood samples by practice nurse at 3 months

Secondary outcome measures

Quality of life, measured using the self-reported EQ-5D-5L at baseline and 3 months

Overall trial start date

31/12/2014

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with primary diagnosis of T2DM and/or hypertension
2. Poorly controlled hypertension and/or T2DM, as indicated by clinical measures or gaps in ordering or filling repeat prescriptions
3. 18 years old and above

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 142; UK Sample Size: 142

Participant exclusion criteria

Patients will be excluded if they:
1. Have a hearing impairment (hearing spectrum lower than 50Hz-20kHz) or a speaking impairment
2. Have a diagnosis of dementia, aphasia or other cognitive difficulties that could affect study participation
3. Have had a recent severe life-threatening event or are under treatment for another long-term condition (e.g. cancer)
4. Receive kidney dialysis
5. Are participating in another study
6. Plan to move from the area in the next 6 months

Recruitment start date

01/11/2017

Recruitment end date

30/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cambridgeshire and Peterborough CCG
Cambridge
CB2 8FH
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

School of Clinical Medicine
Cambridge
CB2 0SP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research Central Commissioning Facility (CCF); Grant Codes: PB-PG-0215-36032

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol has been submitted and reviewed by the ethics committee and is available on request to Dr Katerina Kassavou (kk532@medschl.cam.ac.uk). All additional documents (including study protocol, statistical analysis plan, other material) will be included in publications.

The results of this research project will be written up for publication in peer-reviewed journals. Findings will also be disseminated through national and international conference presentations and other scientific meetings. Participants will be sent a summary of the study findings. Information on the progress of the research and results of this research project will be available on the Behavioural Science Group webpage via the Primary Care Unit website at http://bit.ly/medicaladherence. Professor Stephen Sutton, Dr Katerina Kassavou and Professor Griffin will lead on writing up for publication and dissemination. Estimated date for publication of results is January 2019.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/01/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/08/2017: Internal edit.