Supporting medication adherence in patients prescribed treatment for hypertension Circulatory System Essential (primary) hypertension
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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