A very brief face to face intervention, followed by a text message and/or app intervention to support medication adherence in people prescribed treatment for hypertension in primary care

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: Method of randomisation Randomisation will be stratified by the practitioner conducting the baseline consultation, using the method of random permuted blocks. Patient allocation ratio will be 2:3 (n = 40 usual care : n = 60 intervention). Unequal group sizes has been selected to increase the information obtained about patient’s use and evaluation of the intervention. An online randomization tool (www.sealedenvelope.com) will facilitate randomization during baseline consultations. Although the allocation sequence will be concealed, once a participant is allocated, neither the practitioner nor the patient will be blind to allocation. Control group The practitioner will briefly review the patient’s medication‐taking and blood pressure, as per usual care (e.g. and adjust medication, if necessary). If patient’s most recent blood pressure exceeds 140/90 mmHg, the practitioner will introduce the study, check eligibility criteria and obtain informed consent. The practitioner will then record to an online CRF patient’s basic demographics, mobile phone number, self‐reported adherence to prescribed medication and recent adherence to antihypertensive medication. They will then record the BP values, take a blood sample for full lipid profile and glycated haemoglobin (HbA1c) measurement (if patient has comorbidities of type 2 diabetes, cholesterol) and provided information about urine collection and postage to a central laboratory. Intervention group In addition to the control group, the intervention group will receive a very brief intervention (<5 min) including information about how to register and use the digital intervention (i.e. 3 months text message and/or app intervention). The duration of treatment will be 3 months. The duration of follow up will be approximately 3 months after the baseline consultation. CONDITION: High blood pressure ; Circulatory System ; Essential (primary) hypertension PRIMARY OUTCOME: ; 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study for 3 months.; 2. Attrition rate recorded as the number of participants who consent to participate that remain in the study and complete the follow up measurements at 3 months; SECONDARY OUTCOME: ; 1. Fidelity and engagement with the online CRF measured as the duration and number of activities completed during the baseline consultation; 2. Fidelity and engagement with the text message or app measured as the number and consent of text message and app notifications received, interactions, and interaction time intervals during the 3 months intervention; 3. Medication adherence measured using the 5‐item Medication Adherence Report Scale, two single items, the 8‐item Morisky questionnaire, Cumulative Medication Gap and urine analysis at baseline and follow up; 4. Systolic blood pressure measured using blood pressure monitors at baseline and follow up; 5. Lipoprotein and glycaemic control measured using blood samples at baseline and follow up; INCLUSION CRITERIA: Practitioners (practice nurses, health care assistants): Practitioners will be included if they advise patients with hypertension during annual reviews, medication reviews, blood pressure checks or similar consultations; at least one practitioner will be recruited per practice Patients (patients with high blood pressure): Patients will be included if they: 1. Have a diagnosis of HBP, or comorbidities of HBP type 2 diabetes cholesterol 2. Are prescribed at least one antihypertensive medication for at least six months before study recruitment, as confirmed by practice records 3. Have poorly controlled HBP, as indicated by clinical measures 4. Have a good understanding of English 5. Are able to use mobile phones 6. Have the capacity to provide informed consent
Epistemonikos ID: 22c7321466ad327cbde63c6bd69118f4610e8aa6
First added on: Aug 24, 2024