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Programme on Adherence to Medication (PAM) randomised controlled trial

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82013652
Enrollment
542
Registered
2019-12-09
Start date
2020-11-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supporting medication adherence in patients prescribed treatment for hypertension Circulatory System Essential (primary) hypertension

Interventions

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 digi

Sponsors

University of Cambridge
Lead Sponsor
NHS Cambridgeshire and Peterborough Integrated Care Board
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom, Wales

Contacts

Public ContactStephen Sutton
srs34cam@gmail.com+44 (0)1223 330594

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 9, 2026