HypertensionADAMPANCT03242785
Impact of Self-monitoring of Blood Pressure and Self-titration of Medication in the Control of Hypertension (ADAMPA)
A study testing Self-monitoring/Self-titration in people with Hypertension and Adjustment, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension, Adjustment, Adherence, Medication
- What is being tested?
- Self-monitoring/Self-titration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jul 2017to 25 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
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).
Read the 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.
- Conditions
- Hypertension, Adjustment, Adherence, Medication
- Being tested
- Self-monitoring/Self-titration
- Keywords
- Self-monitoring, Education, Self-titration, antihypertensives
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- 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.
- 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)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months from start of intervention
Secondary outcomes (7)
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
Measured: 6 and 24 months
Mean diastolic blood pressure (DBP) at 6 and 24 months
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
Measured: 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
Measured: 6,12, 24 months
EuroQoL-5D score
Score in the EuroQoL-5D at 6, 12 and 24 months of follow-up
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 6,12,24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start21 Jul 2017
- Primary completion1 Jul 2019
- Study completion25 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN, Carlos III Health Institute
- Responsible party
- Principal investigator, José Sanfelix, Fundación para la Investigación del Hospital Clínico de Valencia
- Investigators
- Gabriel Sanfélix-Gimeno, Dr, Principal investigator, Health Services Research Unit FISABIO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242785
- Sponsor's protocol ID
- ADAMPA
- Other IDs
- 2016-003986-25, 2016
- Acronym
- ADAMPA
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2017
- Last updated
- 19 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38728033Martinez-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.
PubMed 36219303
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT03242785
- Acronym / sponsor ID
- ADAMPA / ADAMPA
- Conditions
- Hypertension, Adjustment, Adherence, Medication
- Keywords
- Self-monitoring, Education, Self-titration, antihypertensives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN, Carlos III Health Institute
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 25 Aug 2020 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-monitoring/Self-titration | Experimental | Other: Self-monitoring/Self-titrationThe 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. |
| Routine care | No intervention | –Patients in this arm will receive routine care for high blood pressure in the primary health care center. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-monitoring/Self-titrationThe 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. | Other | Self-monitoring/Self-titration |
Primary outcome
Mean systolic blood pressure (SBP).
Time frame: 12 months from start of intervention
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
7 secondary outcomes
Mean systolic blood pressure at 6 and 24 months
Time frame: 6 and 24 months
Mean diastolic blood pressure (DBP) at 6 and 24 months
Time frame: 6 and 24 months
Percentage of patients with normal SBP and DBP
Time frame: 6,12, 24 months
EuroQoL-5D score
Time frame: 6,12,24 months
Medication adherence
Time frame: 12 months
Medication persistence
Time frame: 12 months
Therapeutic inertia
Time frame: 6,12,24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Derived from this study: PubMed 38728033Martinez-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.
- Derived from this study: PubMed 36219303Martinez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Sanfélix-Gimeno, Dr principal investigator
Health Services Research Unit FISABIO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-monitoring/Self-titration in people with Hypertension and Adjustment, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean systolic blood pressure (SBP). (time frame: 12 months from start of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03242785, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.