Programme on Adherence to Medication (PAM) randomised controlled trial
| ISRCTN | ISRCTN82013652 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82013652 |
| IRAS number | 268471 |
| Secondary identifying numbers | 268471 v0.2 20-10-19, CPMS 43962, IRAS 268471 |
- Submission date
- 28/10/2019
- Registration date
- 09/12/2019
- Last edited
- 27/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Current plain English summary as of 01/12/2023:
Background and study aims
About 9.5 million people in England and Wales receive treatment for hypertension (high blood pressure) from their general practice. However, many people with hypertension and associated conditions (such as diabetes, heart disease and stroke) do not take their medication as prescribed. Not taking medication reduces how well such treatment works and increases healthcare costs; for example, unused medications cost the NHS in England several hundred million pounds per year.
Primary care practitioners have an important role in supporting patients to adhere to their prescribed medication. However, they have limited time to provide ongoing support for adherence, and their time is expensive.
A potential solution is for practitioners to deliver a very brief intervention during a consultation and to use a digital intervention such as text messaging, smartphone app or web-based intervention to support subsequent adherence. Digital interventions have several advantages: they can be fully automated; provide information that is highly tailored to the individual; be interactive; be available at any time; deliver support in real time; deliver support with high fidelity; and be easily updated. A two-component intervention comprising a very brief intervention from a primary care practitioner plus a digital intervention would be inexpensive to deliver, scalable and potentially cost-effective.
About 90% of UK adults and 67% of those aged 65 years and over use a smartphone, and 96% and 87% respectively use a mobile phone capable of text messaging.
We have developed an intervention comprising a very brief intervention delivered remotely by a practice nurse or healthcare assistant in primary care followed by a digital intervention (text messaging programme or smartphone app): the PAM (Programme on Adherence to Medication) intervention. We have shown the intervention to be acceptable, feasible and potentially effective in supporting medication adherence and reductions in blood pressure in patients prescribed treatment for hypertension, as an adjunct to usual care consultations.
The PAM trial 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 hypertension (high blood pressure), have been prescribed at least one antihypertensive medication, and have poorly controlled blood pressure 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 very brief intervention (VBI) delivered remotely (by phone or videolink) by a healthcare practitioner, followed by a digital intervention (text messaging or smartphone app) for up to 14 months. The control group receive usual care only. Follow up is at 6 and 12 months. Participants will be asked to measure their own blood pressure, provide urine and blood samples, and complete questionnaires.
What are the possible benefits and risks of participating?
The potential benefits of participating are that participants allocated to the intervention group may find the intervention helpful in supporting them to take their medications as prescribed, which will be beneficial to their health. Participants allocated to the control group will not benefit from the intervention, but they may find that participation in general and measurement in particular (e.g. self-monitored home blood pressure measurement) may help them to take their medication as prescribed and control their blood pressure. Both groups of participants will also be contributing to evidence about the effectiveness and cost-effectiveness of the intervention. We believe that the risks of participating are low. At worst the intervention may not be effective, and some participants may find the measurement procedures burdensome. Participants are free to withdraw from the trial at any time, and procedures are in place to address any issues that arise.
Where is the study run from?
University of Cambridge (UK)
NHS Cambridgeshire and Peterborough Integrated Care Board (UK)
When is the study starting and how long is it expected to run for?
October 2020 to September 2024
Who is funding the study?
NIHR Programme Grants for Applied Health Research (UK)
Who is the main contact?
Prof Stephen Sutton srs34@medschl.cam.ac.uk
_____
Previous plain English summary:
Background and study aims
Almost 14.5 million people in the UK 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 support patients to take their tablets as prescribed.
A promising approach is to use digital interventions such as text messaging and smartphone ‘apps’ that are accessible from mobile phones. 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 intervention from the practice nurse or healthcare assistant. Practitioners would give brief medication adherence advice and support to patients during consultations such as blood pressure checks and annual reviews. As part of this, they will ‘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 medication adherence intervention (lasting under five minutes) delivered by a nurse/healthcare assistant, who then ‘signposts’ the patient to (ii) a digital intervention designed to provide ongoing behavioural support between practice visits. The researchers 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 and utility of health. 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, such as type 2 diabetes or high 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 (VBI), followed by a 12-month text message and/or 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 health care professionals has been designed to support medication adherence and to register patients 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?
October 2020 to October 2023
Who is funding the study?
Programme Grants for Applied Research (UK)
Who is the main contact?
Dr Katerina Kassavou, kk532@medschl.cam.ac.uk
Contact information
Public, Scientific, Principal Investigator
University of Cambridge
Primary Care Unit
Department of Public Health and Primary Care
East Forvie Building
Cambridge
CB2 0SR
United Kingdom
 ORCID ID |
0000-0003-1610-0404 |
|---|---|
| Phone | +44 (0)1223 330594 |
| srs34@medschl.cam.ac.uk |
Study information
| Study design | Parallel group multi-centre individually randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Efficacy |
| Participant information sheet | https://cambridge.eu.qualtrics.com/jfe/form/SV_eG4vCL5yilD4jzw |
| Scientific title | Randomised controlled trial of a very brief practitioner-delivered intervention plus a digital intervention to support medication adherence in people prescribed treatment for hypertension in primary care: the Programme on Adherence to Medication (PAM) trial |
| Study acronym | PAM |
| Study objectives | Current study hypothesis as of 01/12/2023: The aim of this trial is to estimate the effectiveness and cost-effectiveness of the PAM intervention to improve medication adherence and reduce blood pressure compared with usual care, to inform a decision on whether to implement the intervention in primary care Previous study hypothesis as of 22/10/2020: This trial aims to assess the effectiveness and cost-effectiveness of the PAM intervention to support blood pressure control and medication adherence in primary care. Previous study hypothesis: Is PAM (cost) effective to support adherence to antihypertensive medications and improve blood pressure as an adjunct to primary care? |
| Ethics approval(s) |
Approved 05/10/2020, Cambridge East Independent Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048181; CambridgeEast.REC@hra.nhs.uk), ref: 19/EE/0354 |
| Health condition(s) or problem(s) studied | Supporting medication adherence in patients prescribed treatment for hypertension |
| Intervention | Current interventions as of 01/12/2023: Intervention group: A very brief intervention (VBI) delivered remotely (by phone or video call) by a practice nurse or healthcare assistant followed by a digital intervention (text messaging or smartphone app), in addition to usual care. Control group: Usual care only. _____ Previous interventions as of 22/10/2020: Intervention group: usual care PLUS a very brief intervention (VBI) facilitated by a practice nurse or health care assistant followed by a 12-month text messaging programme or smartphone app. Comparator group: usual care only. _____ Previous interventions: The intervention group will receive a 1-minute very brief intervention, followed by a 3 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 |
| Primary outcome measure | Current primary outcome measure as of 01/12/2023: Systolic blood pressure obtained from self-monitored home blood pressure measurements at 12-month follow up _____ Previous primary outcome measure as of 22/10/2020: Blood pressure measured using A&D Upper Arm Blood Pressure Monitor at 12 months follow up _____ Previous primary outcome measure: Systolic blood pressure measured using electronic monitoring devices at baseline and at 12 months follow up |
| Secondary outcome measures | Current secondary outcome measures as of 01/12/2023: 1. Medication adherence measured by chemical adherence testing of urine samples, self-report questionnaires and prescription data from practice records, at 12-month follow up 2. Diastolic blood pressure obtained from self-monitored home blood pressure measurements at 12-month follow up 3. Full lipid profile and HbA1c for patients with high cholesterol and type 2 diabetes, respectively, at 12-month follow up 4. Health related quality of life using EQ-5D-5L and resource use questionnaire at 6-month and 12-month follow up 5. Process evaluation using audio recordings of the baseline consultation, log files recording use of the digital interventions, qualitative interviews with practitioners and patients, and self-report questionnaires at 12-month follow up _____ Previous secondary outcome measures as of 22/10/2020: 1. Medication adherence measured by biochemical testing of the urine and by self-reports (i.e. two items from the MARS questionnaire and two additional single-item measures) at 12 months follow up 2. Full lipid profile and glucose levels for a subsample of patients, measured using blood samples at 12 months follow up 3. Quality of life measured using EQ-5D-5L, and resource use using a self-reported questionnaire at 12 months follow up 4. Process evaluation using an audio recording of the VBI, digital log files during the 12-month intervention, interviews and self-reported questionnaires at 12-month follow up _____ Previous 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 study start date | 05/10/2020 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 542 |
| Total final enrolment | 578 |
| Key inclusion criteria | Current inclusion criteria as of 01/12/2023: Patients will be included if they satisfy all the following criteria: 1. Has a diagnosis of hypertension (high blood pressure) 2. Have been prescribed at least one antihypertensive (blood pressure lowering) medication 3. Any Blood Pressure reading higher than 140/90 mmHg OR gaps in collecting repeat prescriptions 4. Can understand English and is able to provide informed consent 5. Has a mobile phone and is familiar with sending and receiving text messages 6. The practice nurse or healthcare assistant is not aware of any other reason why the patient should be excluded _____ Previous inclusion criteria as of 22/10/2020: Patients will be included if they satisfy all six criteria: 1. Have a diagnosis of hypertension (high blood pressure) 2. Have been prescribed at least one antihypertensive (blood pressure lowering) medication 3. Have a most recent blood pressure reading higher than 140/90 mmHg or gaps in collecting repeat prescriptions 4. Can understand English and is able to provide informed consent 5. Have a mobile phone and is familiar with sending and receiving text messages 6. The practice nurse or health care assistant is not aware of any other reason why the patient should be excluded. ______ Previous 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 |
| Key exclusion criteria | Current exclusion criteria as of 01/12/2023: Patients will be excluded if: 1. They have BP > 200/100mm Hg or postural hypotension (>20mm Hg systolic drop) 2. They have a diagnosis of dementia or other cognitive difficulties that could affect study participation 3. They have had a recent severe life-threatening event or are under treatment for another long-term health condition (e.g. cancer) 4. They are taking part in another medication adherence intervention or digital intervention for behaviour change 5. Their BP is not managed by their GP practice _____ Previous 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 |
| Date of first enrolment | 01/11/2020 |
| Date of final enrolment | 30/03/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centre
Department of Public Health and Primary Care
East Forvie Building
Cambridge
CB2 0SR
United Kingdom
Sponsor information
University/education
Research Governance Office
School of Clinical Medicine
University of Cambridge
Cambridge Biomedical Campus
Box 111, Hills Road
Cambridge
CB2 0SP
England
United Kingdom
| Phone | +44 (0)1223 769291 |
|---|---|
| cad50@medschl.cam.ac.uk | |
| Website | https://researchgovernance.medschl.cam.ac.uk |
"ROR" |
https://ror.org/013meh722 |
Hospital/treatment centre
Gemini House
Bartholomew’s Walk
Cambridgeshire Business Park
Angel Drove
Ely
CB7 4EA
England
United Kingdom
| alexander.phillips3@nhs.net | |
| Website | https://sites.google.com/nihr.ac.uk/cpresearch |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Programme Grants for Applied Research, PGfAR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Current publication and dissemination plan; Planned publication in high-impact peer-reviewed journals Previous publication and dissemination plan as of 14/08/2023: Planned publication of the main trial in a high-impact peer-reviewed journal. This programme's lead researcher and the first author is Dr Aikaterini Kassavou, katerina, kassavou@gmail.com. Dr Kassavou will lead the publications and dissemination plan for the WS4 and WS5; that is the results for the main randomised controlled trial, including the intervention effectiveness and cost-effectiveness, as well as the mixed methods process evaluation. For more information see https://osf.io/qfgx7/ Previous publication and dissemination plan as of 08/12/2022: Planned publication of the main trial in a high-impact peer-reviewed journal. This programme's lead researcher and the first author is Dr Aikaterini Kassavou, katerina.kassavou@gmail.com. Dr Kassavou will lead the publications and dissemination plan for the WS4 and WS5; that is the results for the main randomised controlled trial, including the intervention effectiveness and cost-effectiveness, as well as the mixed methods process evaluation. Previous publication and dissemination plan as of 09/05/2022: Planned publication of the main trial in a high-impact peer-reviewed journal. The lead researcher and first author Dr Aikaterini Kassavou will lead the publication and dissemination plan for the main trial, including the intervention effectiveness and cost-effectiveness, and the process evaluation. Previous publication and dissemination plan from 29/11/2021: Planned publication of the main trial in a high-impact peer-reviewed journal. Previous 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 plan | Current Individual participant data (IPD) sharing plan as of 01/12/2023: The current data sharing plans for this study are unknown and will be available at a later date Previous IPD sharing statement as of 08/12/2022: The datasets generated during and/or analysed during the current study are/will be available upon request from the lead and first author Dr Aikaterini Kassavou (katerina.kassavou@gmail.com). Type of data: primary data for systolic blood pressure and biochemical medication adherence When the data will become available: after publication in 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). Previous IPD sharing statement as of 29/11/2021: The datasets generated during and/or analysed during the current study are/will be available upon request from the lead and first author Dr Aikaterini Kassavou (kk532@medschl.cam.ac.uk). Type of data: primary data for systolic blood pressure and biochemical medication adherence When the data will become available: after publication in 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). Previous 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 15/09/2020 | 24/01/2022 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Additional files
Editorial Notes
27/02/2204: Internal review.
04/12/2023: The following changes were made to the trial record:
1. The contact was changed.
2. The sponsor "The Cambridgeshire and the Peterborough Clinical Commissioning Group" was removed and "NHS Cambridgeshire and Peterborough Integrated Care Board" was added.
3. The plain English summary was updated to reflect these changes.
01/12/2023: The following changes were made to the trial record:
1. A poster was removed as it was not supposed to be published.
2. The public title was changed from "Programme on Adherence to Medication" to "Programme on Adherence to Medication (PAM) randomised controlled trial".
3. The scientific title was changed from "Programme on Adherence to Medication (PAM): a very brief nurse-led intervention, followed by a text message or a smartphone app to support medication adherence in people prescribed treatment for hypertension in primary care. A randomised controlled trial" to "Randomised controlled trial of a very brief practitioner-delivered intervention plus a digital intervention to support medication adherence in people prescribed treatment for hypertension in primary care: the Programme on Adherence to Medication (PAM) trial".
4. The IRAS number was added.
5. The study hypothesis was changed.
6. The study design was changed from "Randomized controlled trial" to "Parallel group multicentre individually randomized controlled trial".
7. The study type was changed from treatment to efficacy.
8. The overall end date was changed from 30/10/2023 to 30/09/2024.
9. The condition was changed from "Hypertension (high blood pressure)" to "Supporting medication adherence in patients prescribed treatment for hypertension".
10. The interventions were changed.
11. The primary outcome measure was changed.
12. The secondary outcome measures were changed.
13. The inclusion criteria were changed.
14. The target number of participants was changed from 570 to 578.
15. The exclusion criteria were changed.
16. The study participating centre University College London was changed to University of Cambridge.
17. The plain English summary was updated to reflect these changes.
18. The participant level data sharing statement
19. The intention to publish date was changed from 31/08/2024 to 30/09/2024.
20. The publication and dissemination plan was changed.
28/11/2023: Internal review.
14/08/2023: The following changes were made:
1. The publication and dissemination plan has been updated.
2. Poster added.
05/06/2023: The following changes were made:
1. The recruitment end date was changed from 30/06/2023 to 30/03/2022.
2. The overall end date was changed from 31/08/2023 to 30/10/2023.
3. The intention to publish date was changed from 30/10/2023 to 31/08/2024.
4. The plain English summary was updated to reflect these changes.
5. The study participating centre was changed from University of Cambridge to University College London
6. The total final enrolment was added.
08/12/2022: The following changes have been made:
1. The publication and dissemination plan has been updated.
2. The IPD sharing statement has been changed.
3. A public contact was added.
09/05/2022: The publication and dissemination plan was updated.
25/01/2022: The overall trial start date was changed from 17/10/2016 to 05/10/2020.
24/01/2022: Uploaded protocol (not peer reviewed). Trial website and link to participant information sheet added.
29/11/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2022 to 30/06/2023.
2. The overall trial end date has been changed from 31/10/2022 to 31/08/2023 and the plain English summary updated accordingly.
3. The plain English summary has been changed.
4. The publication and dissemination plan has been changed.
5. The IPD sharing statement has been changed.
6. The intention to publish date has been changed from 30/10/2022 to 30/10/2023.
22/10/2020: The following changes were made to the trial record:
1. The scientific title was changed from '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 ' to 'Programme on Adherence to Medication (PAM): a very brief nurse-led intervention, followed by a text message or a smartphone app to support medication adherence in people prescribed treatment for hypertension in primary care. A randomised controlled trial'.
2. The study hypothesis, interventions, primary and secondary outcome measures, inclusion criteria, and plain English summary were updated.
3. The overall trial start date was changed from 03/02/2020 to 17/10/2016.
4. The overall trial end date was changed from 31/08/2022 to 31/10/2022.
5. The target number of participants was changed from 764 to 542.
6. The recruitment start date was changed from 02/03/2020 to 01/11/2020.
7. The recruitment end date was changed from 30/07/2021 to 30/06/2022.
8. Ethics approval details added.
01/05/2020: Due to current public health guidance, recruitment for this study has been paused.
