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A novel approach to GP-patient interactions to improve outcomes in older people with high blood pressure

Supporting GPs and people with hypertension to maximise medication use to control blood pressure: the MIAMI cluster pilot randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN85009436
Enrollment
60
Registered
2023-01-17
Start date
2022-11-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Hypertension Circulatory System Hypertensive diseases

Interventions

The MIAMI intervention is a structured set of supports for GPs and patients with hypertension to facilitate adequate information exchange about long-term antihypertensive medication use and adherence

Sponsors

University of Galway
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria for patient participants: 1. Have a confirmed diagnosis of hypertension 2. Participants must be on two or more anti-hypertensive medications 3. Participants must not be achieving recommended blood pressure levels i.e. clinic readings are higher than 140/90 mmHg or day ABPM 135/85 mmHg 4. In the judgement of the GP regarding a change in medication, the balance of risk/benefit lies in favour of benefit Inclusion criteria for GP practices: 1. Within the catchment area of the biochemistry lab at University Hospital Galway 2. Using Socrates software system Inclusion criteria for GP participants: Doctors who are providing patient care in the practice

Exclusion criteria

Exclusion criteria: Patient participants: 1. Unable to give informed consent 2. Resident in a nursing home

Design outcomes

Primary

MeasureTime frame
Acceptability and feasibility of the intervention and a future definitive RCT. This will be measured through: 1. Recruitment of GP practices will be assessed by documenting the number of invitations sent, the number of refusals and the number of acceptances throughout the study 2. Recruitment of patients will be assessed by documenting the number of invitations sent, the number of initial responses, the number of follow-up phone calls required, the number of refusals and the number of acceptances throughout the study 3. Attrition of participants will be documented at every timepoint throughout the study 4. Levels of missing data in returned questionnaires will be reported at baseline and follow up 5. The comprehensibility and acceptability of all questionnaires will be measured by asking participants how the questionnaires might be improved and how long they took to complete at baseline and follow up 6, The perceptions and experiences of people with hypertension and GPs of participating in the MIAMI intervention and their views as to the feasibility and acceptability of the intervention, explored using qualitative interviews at the mid-point of the intervention

Secondary

MeasureTime frame
1. Systolic blood pressure (ambulatory blood pressure monitoring [ABPM], average reading) measured at baseline and follow up 2. Diastolic blood pressure (ABPM, average reading) measured at baseline and follow up 3. Blood pressure control (ABPM, reading above or below 140/90mmHg) measured at baseline and follow up 4. Medication adherence (urine screen, prescription refill records, Medication Adherence Report Scale (MARS) measured at baseline and follow up 5. Beliefs about medication (Beliefs about Medication Questionnaire (BMQ), Illness Perceptions Questionnaire - Revised (IPQ-R) 'treatment control' and 'consequences' items) measured at baseline and follow up 6. Habit strength measured using the Self-Report Behavioural Automaticity Index (SRBAI) at baseline and follow up 7. Pill burden (type and dosage) measured at baseline and follow-up 8. Health related quality of life measured using EuroQol-5D-5L at baseline and follow-up 9. Wellbeing measured using ICEpop CAPability measure for Older people (ICECAP-O) at baseline and follow up

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026