Condition category
Circulatory System
Date applied
28/10/2019
Date assigned
09/12/2019
Last edited
01/05/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
Almost eight million people in England receive treatment for high blood pressure (hypertension) from their general practice, including many patients with other conditions such as diabetes, heart disease and stroke. Treatment for high blood pressure usually consists of one or more blood-pressure-lowering medicines, known as antihypertensives. Many patients will also be prescribed other medicines including statins (to lower cholesterol) and glucose-lowering medicines. Taking medication as prescribed can significantly reduce risks, complications and early deaths associated with these conditions. However, many people with these conditions do not take their medication as prescribed. This reduces how well such treatment works, leading to increased heart attacks and strokes. It also means that a lot of medicines are wasted, which costs the NHS several hundred million pounds a year.
GPs and nurses can support patients in taking their medication, but they have limited time and their time is expensive. There is, therefore, a need for low-cost interventions that help patients to take their tablets as prescribed. A promising approach is to use digital interventions such as text messaging, smartphone ‘apps’, and internet-based interventions that are accessible from smartphones. Such interventions have several advantages: they can be fully automated; they can provide information that is highly tailored to the individual; they can be interactive; they can be available at any time; they can deliver support in real-time; the content can be easily updated; and, once they have been developed, they are relatively inexpensive to deliver.
The researchers are proposing that a digital intervention could be used in combination with a brief face-to-face intervention from the practice nurse or healthcare assistant. Practitioners would give brief advice and support to patients during consultations such as blood pressure checks and annual reviews. As part of this, they would ‘signpost’ patients to a digital intervention which would support them to take their medicines between visits to the practice.
With the help of patients, practitioners and other experts, and informed by a review of existing evidence, the researchers will develop a new intervention that has two parts: (i) a very brief face-to-face intervention (lasting under five minutes) delivered by a practice nurse/healthcare assistant that ‘signposts’ the patient to (ii) a digital intervention designed to provide ongoing support between practice visits. They will test whether this two-part intervention is feasible and acceptable to patients and practitioners. Then they will test whether the intervention helps people take their medicines as prescribed and reduces their blood pressure (i.e. whether it is effective) compared with usual care, and also whether it provides value for money. If the findings are positive, the intervention could be rapidly implemented in the NHS, with immediate and long-term benefits to patients and to the health service.

Who can participate?
Patients who have a diagnosis of high blood pressure (HBP), or comorbidities of HBP type 2 diabetes cholesterol, are prescribed at least one antihypertensive medication, and have poorly controlled HBP or gaps in collecting repeat prescriptions

What does the study involve?
Participants are randomly allocated to the intervention group or the control group. The intervention group receive a 1-minute very brief intervention, followed by a three months text message and/or a smartphone app intervention. The control group receive usual care only. Follow up is at 12 months.

What are the possible benefits and risks of participating?
The VBI delivered by the primary care professionals has been designed to facilitate patients’ reasons of medication non-adherence and to enrol them into the text messaging or app intervention. The researchers will use this information to make recommendations to health care providers in primary care about how best to support people take their prescribed medications by delivering very brief advice. The text messaging service and app intervention has been designed to reflect research which suggests digital interventions may enhance medication adherence by providing ongoing support following practitioners’ consultations. This intervention will be available to provide advice on taking medications and support patients to self-monitor their medication taking. It is anticipated that this element of the digital intervention will increase patients' satisfaction with the continuous care they receive from the practice. If feasible, this low-cost intervention could reach people even in the most deprived areas. Practitioners may not directly benefit from the study, but if successful, this intervention may benefit people with long-term health conditions and help other practitioners to achieve practice QOF targets. Furthermore, medication non-adherence reduces the effectiveness of treatment and increases the cost to the NHS from hospital admissions, additional consultations, referrals, investigations and medicine wastage. If this scalable intervention is effective it will most probably be a cost-effective intervention for the NHS. This is a behavioural intervention and does not involve the test of any medical device/equipment or drugs. Thus, in the researchers’ view, this is a low-risk study.

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

When is the study starting and how long is it expected to run for?
February 2020 to August 2022

Who is funding the study?
Programme Grants for Applied Research (UK)

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katerina Kassavou

ORCID ID

Contact details

University of Cambridge
School of Clinical Medicine
Department of Public Health and Primary Care
Forvie Site
Robinson Way
Cambridge
CB2 0SR
United Kingdom
+44 (0)1223 330456
kk532@medschl.cam.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

268471 v0.2 20-10-19, CPMS 43962

Study information

Scientific title

Programme on Adherence to Medication (PAM): A very brief face to face intervention, followed by a text message and/or smartphone app intervention to support medication adherence in people prescribed treatment for hypertension in primary care. A randomised controlled trial

Acronym

PAM

Study hypothesis

Is PAM (cost) effective to support adherence to antihypertensive medications and improve blood pressure as an adjunct to primary care?

Ethics approval

Approval pending, East of England - Cambridge East Research Ethics Committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Hypertension (high blood pressure)

Intervention

The intervention group will receive a 1-minute very brief intervention, followed by a three months text message and/or a smartphone app intervention. The control group will receive usual care only. Follow up will be at 12 months. Randomisation will be stratified by primary care professionals only.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Systolic blood pressure measured using electronic monitoring devices at baseline and at 12 months follow up

Secondary outcome measures

1. Medication adherence measured by urine samples, two self-reported items, and MARS at baseline and 12 months follow up
2. Quality of life measured using EQ5-D at baseline and at 12 months
3. Process evaluation using digital log files and audio-files during the 3-months intervention, and self-reported questionnaires at baseline and 12 months

Overall trial start date

03/02/2020

Overall trial end date

31/08/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients will be included if they:
1. Have a diagnosis of high blood pressure (HBP), or comorbidities of HBP type 2 diabetes cholesterol
2. Are prescribed at least one antihypertensive medication
3. Have poorly controlled HBP or gaps in collecting repeat prescriptions
4. Are able and use mobile phones
5. Have the capacity to provide informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

764

Participant exclusion criteria

Patients will be excluded if they:
1. Have a diagnosis of dementia or other cognitive difficulties that could affect study participation
2. Have had a recent severe life-threatening event or are under treatment for another long-term health condition (e.g. cancer)
3. Take part in another medication adherence and/or digital intervention

Recruitment start date

02/03/2020

Recruitment end date

30/07/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Cambridge
School of Clinical Medicine Department of Public Health and Primary Care Forvie Site Robinson Way
Cambridge
CB2 0SR
United Kingdom

Sponsor information

Organisation

The University of Cambridge

Sponsor details

School of Clinical Medicine
Department of Public Health and Primary Care
Forvie Site
Robinson Way
Cambridge
CB2 0SR
United Kingdom
+44 (0)1223 769291
cad50@medschl.cam.ac.uk

Sponsor type

University/education

Website

Organisation

The Cambridgeshire and the Peterborough Clinical Commissioning Group

Sponsor details

Lockton House
Clarendon Road
Cambridge
CB2 0SR
United Kingdom
-
v.shaw@nhs.net

Sponsor type

Hospital/treatment centre

Website

https://sites.google.com/nihr.ac.uk/cpresearch/about-us

Funders

Funder type

Government

Funder name

Programme Grants for Applied Research

Alternative name(s)

NIHR Programme Grants for Applied Research, PGfAR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. The protocol is currently under ethics review. It will be available for publication after the study is approved from ethics and when recruitment is underway.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Aikaterini Kassavou (kk532@medschl.cam.ac.uk).
Type of data: primary data for systolic blood pressure and medication adherence
When the data will become available: after publication to peer-review journals
What access criteria data will be shared including with whom: data will be shared with researchers conducting secondary analysis of RCTs (e.g. meta-analysis).

Intention to publish date

30/10/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/05/2020: Due to current public health guidance, recruitment for this study has been paused.