Clinical trial NCT03242785: Impact of Self-monitoring of Blood Pressure and Self-titration of Medication in the Control of Hypertension (ADAMPA)
Official title: Impact of Self-monitoring of Blood Pressure and Self-titration of Antihypertensive Medication in the Control of Hypertension and Adherence to Treatment. A Pragmatic, Randomized, Controlled Clinical Trial (ADAMPA Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Adjustment
Adherence, Medication
Keywords: Self-monitoring
Education
Self-titration
antihypertensives
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
name: Carlos III Health Institute
First posted: 2017-08-08
Enrollment: 366
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 40 years or older
* Diagnosis of hypertension of any origin
* Systolic blood pressure (SBP) \> 145 or diastolic blood pressure (DBP) \> 90 mm Hg at baseline
* Voluntarily participation in the study and having signed the corresponding informed consent.

Exclusion Criteria:

* Inability to understand and/or perform self-adjustment of the medication, including dementia or significant cognitive impairment (at the discretion of the investigator performing the recruitment).
* History of orthostatic hypotension (fall\> 20 mm Hg in SBP after adopting the orthostatic position).
* SBP\> 200 or DBP\> 100 mm Hg on the baseline examination
* Being on treatment with more than 4 antihypertensive drugs
* Participation in another study on high blood pressure or in a clinical trial
* Presence of tremor or neurological disease that makes it difficult to perform BP self-measurement.
* Presence of arrhythmia
* Presence of terminal illness
* Chronic disability impeding to leave home
* History of acute cardiovascular event in the last 3 months
* Hypertension managed directly by specialist physicians outside the primary care setting.
* Spouse selected for the study
* Non-resident or transient patients
* Pregnancy

Primary outcomes:
measure: Mean systolic blood pressure (SBP).
timeFrame: 12 months from start of intervention
Secondary outcomes:
measure: Mean systolic blood pressure at 6 and 24 months
timeFrame: 6 and 24 months
measure: Mean diastolic blood pressure (DBP) at 6 and 24 months
timeFrame: 6 and 24 months
measure: Percentage of patients with normal SBP and DBP
timeFrame: 6,12, 24 months
measure: EuroQoL-5D score
timeFrame: 6,12,24 months
measure: Medication adherence
timeFrame: 12 months
measure: Medication persistence
timeFrame: 12 months
measure: Therapeutic inertia
timeFrame: 6,12,24 months
Other outcomes:
measure: Changes in lifestyle
timeFrame: 6,12,24 months
measure: Adverse events
timeFrame: 12 months
measure: Health services utilization
timeFrame: 6,12 and 24 months
measure: Incremental cost per quality-adjusted life year gained
timeFrame: 12 months
measure: Satisfaction with the intervention
timeFrame: 12 months
Locations:
city: Valencia
country: Spain
facility: Departamento de Salud Valencia Clínico Malvarrosa
Study officials:
affiliation: Health Services Research Unit FISABIO
name: Gabriel Sanfélix-Gimeno, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.