NCT03242785

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2020

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

August 2, 2017

Last Update Submit

August 18, 2021

Conditions

HypertensionAdjustmentAdherence, Medication

Keywords

Self-monitoringEducationSelf-titrationantihypertensives

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Mean systolic blood pressure at 6 and 24 months

    6 and 24 months

  • Mean diastolic blood pressure (DBP) at 6 and 24 months

    6 and 24 months

  • Percentage of patients with normal SBP and DBP

    6,12, 24 months

  • EuroQoL-5D score

    6,12,24 months

  • Medication adherence

    12 months

  • +2 more secondary outcomes

Other Outcomes (5)

  • Changes in lifestyle

    6,12,24 months

  • Adverse events

    12 months

  • Health services utilization

    6,12 and 24 months

  • +2 more other outcomes

Study Arms (2)

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.

Other: Self-monitoring/Self-titration

Routine care

NO INTERVENTION

Patients in this arm will receive routine care for high blood pressure in the primary health care center.

Interventions

Self-monitoring/Self-titrationOTHER

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: 1. Education of the patient: information and training on hypertension, its risks, management, the benefits of an adequate control and the generic measures for an optimal control. 2. Training for self-monitoring: Patients will be trained to perform the self-measurement of blood pressure correctly (and recording their values in the sheet enabled for this purpose) 3. Training for self-titration: patients will be instructed on the target BP numbers, individualized for each patient, on the mode of action against specific figures, including self-adjustment of drug treatment.

Self-monitoring/Self-titration

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Salud Valencia Clínico Malvarrosa

Valencia, Spain

Location

Related Publications (2)

  • 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.

    PMID: 38728033DERIVED

  • 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.

    PMID: 36219303DERIVED

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Gabriel Sanfélix-Gimeno, Dr

    Health Services Research Unit FISABIO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Care Physician

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 8, 2017

Study Start

July 21, 2017

Primary Completion

July 1, 2019

Study Completion

August 25, 2020

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)