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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003986-25 | EudraCT Number |
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| Name | Class |
|---|---|
| Spanish Clinical Research Network - SCReN | NETWORK |
| Carlos III Health Institute | OTHER_GOV |
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The ADAMPA study is a pragmatic randomized clinical trial which aims to evaluate the effectiveness of an intervention based on self-monitoring and self-titration of medication in poorly controlled hypertensive patients 40 years and older. The total duration of the study is 3 years, with 6 months of enrolment and 1 year of follow-up to measure the primary endpoint (Difference in mean systolic blood pressure, in mmHg, between the intervention and control groups).
ADAMPA study. Objectives: To evaluate the comparative effectiveness of an intervention that includes educational components, self-monitoring of blood pressure and self-titration of antihypertensive medication in the improvement of control of hypertension compared to usual care in a poorly controlled population of hypertensive patients.
Design: Pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms.
Disease related to the study: Hypertension.
Main outcome measure: Difference in mean systolic blood pressure, in mmHg. At 12 months of follow-up between the intervention and control groups, determined at physicians' practice with a validated automatic electronic sphygmomanometer
Study population: Patients assigned to the Valencia Clinic-La Malvarrosa Health Department. Total number of patients to be randomized: 458 (229 per arm).
Duration of intervention: 12 months (also, a pragmatic extension with passive follow-up is planned for 24 months, collecting a reduced set of outcome variables, as secondary variables)
Calendar and expected completion date: The trial will take place over 3 years (6 months of recruitment, 12 months of follow-up for the main analysis of results, 12 months of pragmatic follow-up at 24 months, and finally 6 months for reporting results). Estimated Completion Date: 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-monitoring/Self-titration | Experimental | The intervention consists of self-monitoring blood pressure at home, and subsequent medication self-titration, based on a medication adjustment plan pre-established by the family physician, in patients with uncontrolled hypertension. |
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| Routine care | No Intervention | Patients in this arm will receive routine care for high blood pressure in the primary health care center. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-monitoring/Self-titration | Other | The intervention of the ADAMPA trial is not pharmacological but an intervention that modifies usual clinical practice. The intervention of self-monitoring and self-titration of the medication is composed of 3 elements:
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| Measure | Description | Time Frame |
|---|---|---|
| Mean systolic blood pressure (SBP). | Difference in mean systolic blood pressure, in mmHg. At 12 months of follow-up between the intervention and control groups, determined at physicians' practice with a validated automatic electronic sphygmomanometer | 12 months from start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Mean systolic blood pressure at 6 and 24 months | Difference in mean systolic blood pressure, in mmHg at 6 and 24 months of follow-up between intervention and control groups determined at physicians' practice with a validated automatic electronic sphygmomanometer | 6 and 24 months |
| Mean diastolic blood pressure (DBP) at 6 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lifestyle | Changes in lifestyle (smoking, exercise, body weight) at 6, 12, and 24 months compared to these characteristics at baseline. | 6,12,24 months |
| Adverse events | We will assess if any of the following adverse events are present during the follow-up: angor, myocardial infarction, stroke, hypotensive crisis and death. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Sanfélix-Gimeno, Dr | Health Services Research Unit FISABIO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departamento de Salud Valencia Clínico Malvarrosa | Valencia | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38728033 | Derived | Martinez-Ibanez P, Marco-Moreno I, Garcia-Sempere A, Peiro S, Martinez-Ibanez L, Barreira-Franch I, Bellot-Pujalte L, Avelino-Hidalgo E, Escrig-Veses M, Boveda-Garcia M, Calleja-Del-Ser M, Robles-Cabaninas C, Hurtado I, Rodriguez-Bernal CL, Gimenez-Loreiro M, Sanfelix-Gimeno G, Sanfelix-Genoves J; ADAMPA Research Group. Long-Term Effect of Home Blood Pressure Self-Monitoring Plus Medication Self-Titration for Patients With Hypertension: A Secondary Analysis of the ADAMPA Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410063. doi: 10.1001/jamanetworkopen.2024.10063. | |
| 36219303 |
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|
Difference in mean diastolic blood pressure, in mmHg at 6 and 24 months of follow-up between intervention and control groups determined at physicians' practice with a validated automatic electronic sphygmomanometer |
| 6 and 24 months |
| Percentage of patients with normal SBP and DBP | Percentage of patients with SBP<140 mmHg and DBP <90 mmHg at 6, 12 y 24 months of follow-up | 6,12, 24 months |
| EuroQoL-5D score | Score in the EuroQoL-5D at 6, 12 and 24 months of follow-up | 6,12,24 months |
| Medication adherence | Proportion of days covered (PDC) will be measured, dividing the number of days with dispensed medication by the number of days of follow-up. Patients with PDC ≥ 80 will be considered adherent. In case of polypharmacy, patients with PDC ≥ 80 for all the medications will be considered adherent. | 12 months |
| Medication persistence | Persistence will be defined as the time of continuous utilization of the correspondent medication from the start of follow-up until its discontinuation (when the patient stops picking up the medication after a 60-days grace period, once the period with available medication from the previous dispensation is finished). | 12 months |
| Therapeutic inertia | Defined as the quotient resulting of dividing the number of patients whose pharmacological treatment has not been modified, by the number of patients with SBP and/or DBP measured in the physician's practice, with values above the recommendations of the European Society of Hypertension and European Society of Cardiology. This measurements will be performed at 6, 12 and 24 months. | 6,12,24 months |
| 12 months |
| Health services utilization | Health services utilization during follow-up (6, 12 and 24 months), will include: visits to primary care nurse and physician, related to high blood pressure (HBP) (including telephone and home), emergency visits to hospital, hospital admissions, hospitalization days per admission and principal diagnosis. | 6,12 and 24 months |
| Incremental cost per quality-adjusted life year gained | Incremental cost per quality-adjusted life year gained in the intervention group as compared to the control group. | 12 months |
| Satisfaction with the intervention | Qualitative evaluation of the intervention by patients and research physicians, through a satisfaction scale. | 12 months |
| Derived |
| Martinez-Ibanez P, Marco-Moreno I, Peiro S, Martinez-Ibanez L, Barreira-Franch I, Bellot-Pujalte L, Avelino-Hidalgo E, Escrig-Veses M, Boveda-Garcia M, Calleja-Del-Ser M, Ferrero-Gregori A, Iftimi AA, Hurtado I, Garcia-Sempere A, Rodriguez-Bernal CL, Gimenez-Loreiro M, Sanfelix-Gimeno G, Sanfelix-Genoves J; ADAMPA research group. Home Blood Pressure Self-monitoring plus Self-titration of Antihypertensive Medication for Poorly Controlled Hypertension in Primary Care: the ADAMPA Randomized Clinical Trial. J Gen Intern Med. 2023 Jan;38(1):81-89. doi: 10.1007/s11606-022-07791-z. Epub 2022 Oct 11. |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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