Cardiometabolic conditions Nutritional, Metabolic, Endocrine
Conditions
Interventions
There will be two main elements to this study – a cross-sectional observational study conducted in primary care practices, and a qualitative study. This will allow both the collection of adherence rat
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for observational study: 1. Adults (aged >=18 years) 2. Receiving a prescription for >=3 antihypertensive medications, at least one of which has been prescribed for over a year 3. Displaying signs of uncontrolled hypertension (systolic BP =140 mmHg and/or diastolic BP =90 mmHg; previously BP >140/90 mmHg), an indicator of medication nonadherence 4. With cardiometabolic MLTCs (hypertension plus at least one of diabetes, chronic kidney disease (CKD – stage G3A1 and above), CVD or heart failure) 5. Willing and able to consent to participate in the study Inclusion criteria for qualitative study: For the qualitative study, the inclusion criteria for patients will be: 1. Adults (aged >=18 years) 2. Receiving a prescription for >=3 antihypertensive medications, at least one of which has been prescribed for over a year 3. Willing and able to consent to participate in the study 4. Access to information technology (if required to participate in remote interviews) 5. Ability to understand English (for focus group attendance only) For HCPs participating in the qualitative study, the inclusion criteria will be: 1. Nurses, doctors, pharmacists and other HCPs from primary care involved in the management of patients with hypertension 2. Participant is willing and able to give informed consent to participate in the study 3. Participant is able (in the Investigator's opinion) and willing to fulfil all the study requirements 4. Access to information technology (if required to participate in remote interviews)
Exclusion criteria
Exclusion criteria: Exclusion criteria for observational study: 1. Coded as terminally ill, housebound or in residential care 2. Unable to understand a language in which it is possible to provide the study material or support understanding of the study through the assistance of an interpreter Exclusion criteria for qualitative study: For the qualitative study, the exclusion criteria for patients will be: 1. Coded as terminally ill, housebound or in residential care 2. No access to information technology (if required to participate in remote interviews) 3. Unable to understand English (for focus group attendance only) For HCPs participating in the qualitative study, the exclusion criteria will be: 1. Not involved in the care or management of patients with hypertension 2. No access to information technology (if required to participate in remote interviews)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medication adherence status to antihypertensive medications, identified using chemical adherence testing (CAT) at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood pressure, measured in clinic using a sphygmomanometer at baseline 2. Blood lipids, obtained from electronic healthcare records at baseline 3. HbA1c (in people with diabetes), obtained from electronic healthcare records at baseline 4. eGFR, obtained from electronic healthcare records at baseline 5. Urine albumin-to-creatinine ratio (ACR), obtained from electronic healthcare records at baseline 6. Quality of life, assessed using the EQ-5D-5L at baseline 7. Depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline 8. Self-reported antihypertensive medication adherence, assessed using the Hill Bone Compliance to High Blood Pressure Therapy Scale at baseline 9. Weight, height and body mass index (BMI), measured directly at baseline 10. Demographics and equality data, asked directly to the participant at baseline: age, sex, ethnicity, index of multiple deprivation, smoking status, first spoken language, religion, highest education attained, home blood pressure monitoring status 11. Prescribed antihypertensive medications, assessed using electronic healthcare records at baseline 12. Total number of current repeat prescriptions, obtained from electronic healthcare records at baseline 13. Diagnosis of other conditions, including CKD, CVD, diabetes, heart failure and depression, obtained from electronic healthcare records at baseline 14. Previous number of ‘Did Not Attend’ instances, obtained from electronic healthcare records at baseline 15. Recruitment rates, key demographic factors of those recruited vs not recruited, identification of any barriers to recruitment assessed via study documents 16. Barriers, facilitators and attitudes towards antihypertensive medication adherence and chemical adherence testing assessed using either 1:1 semi-structured interviews or focus groups at a follow-up visit | — |
Countries
England, United Kingdom
Contacts
Public ContactPatrick Highton
Outcome results
None listed