What question did this study set out to answer?

To assess whether primary care self-management comprising home blood pressure monitoring, education, and medication self-titration decreases systolic blood pressure more effectively than usual care in poorly controlled hypertension.

September 24, 2018BMC Family PracticeOpen Access

Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Poorly controlled hypertension (n=458). Intervention: Self-monitoring blood pressure at home (SMBP) and self-titration of antihypertensive medication vs. Usual care. Primary outcome: Change in mean systolic blood pressure (SBP) between baseline and 12 months.

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Key result

The ADAMPA trial is a planned pragmatic randomized controlled trial designed to evaluate whether self-monitoring of blood pressure and self-titration of medication reduces systolic blood pressure compared to usual care.

Why the study?

Does self-management with home blood pressure monitoring and self-titration of medication decrease systolic blood pressure compared to usual care in patients with poorly controlled hypertension?

Population

Patients with poorly controlled hypertension in the primary care setting

Comparison

Self-management including educational… vs Usual care (including educational components)

Design

RCT, 1:1, unblinded

Follow-up

12 months

Authors

JSJosé Sanfélix‐GenovésFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana CRClara L. Rodríguez‐BernalFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana IMIrene Marco-MorenoFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Discussion

Member takes

Implication

This study protocol outlines a pragmatic trial to evaluate whether self-monitoring and self-titration of antihypertensive medication can improve blood pressure control in primary care.

Key Points

To assess whether primary care self-management comprising home blood pressure monitoring, education, and medication self-titration decreases systolic blood pressure more effectively than usual care in poorly controlled hypertension.
Pragmatic, unblinded randomized clinical trial allocating primary care patients with poorly controlled hypertension in a 1:1 ratio to self-management or usual care over a 12-month period (EudraCT: 2016-003986-25).
The self-management arm receives educational components, self-measured blood pressure monitoring (SMBP), and antihypertensive medication self-titration according to a general practitioner's pre-established plan.
The control arm receives standard primary care supplemented with identical educational components.
As a trial protocol, quantitative comparative outcomes and effect estimates for the primary endpoint remain pending study completion.
The primary outcome evaluation is designed to determine the net reduction in systolic blood pressure over 12 months of follow-up.
Expected outcomes aim to assess the viability of patient-driven care in achieving blood pressure targets and supporting public health service sustainability.

Study Design

Type

RCT (n=458)

Blinding

Unblinded

Randomization

1:1 ratio using a computer randomization system via internet with minimization

Multicenter

Yes

Structured PICO

Does self-management with home blood pressure monitoring and self-titration of medication decrease systolic blood pressure compared to usual care in patients with poorly controlled hypertension?

Population

Planned trial of 458 patients aged 40 years or older with poorly controlled hypertension managed in primary care, followed for 12 months.

Intervention

Self-management including educational components, self-measured blood pressure monitoring at home (SMBP), and self-titration of antihypertensive medication based on a general practitioner's pre-established adjustment plan

Comparator

Usual care (including educational components)

Outcome

Decrease in systolic blood pressuresurrogate

This study protocol outlines a pragmatic trial to evaluate whether self-monitoring and self-titration of antihypertensive medication can improve blood pressure control in primary care.

Limitations

This is a study protocol and does not report clinical results.
Unblinded design may introduce bias.

Cite This Study

Sanfélix‐Genovés et al. (2018) conducted an RCT in Poorly controlled hypertension (n=458). Self-monitoring blood pressure at home (SMBP) and self-titration of antihypertensive medication vs. Usual care was evaluated on Change in mean systolic blood pressure (SBP) between baseline and 12 months. The ADAMPA trial is a planned pragmatic randomized controlled trial designed to evaluate whether self-monitoring of blood pressure and self-titration of medication reduces systolic blood pressure compared to usual care.

synapsesocial.com/papers/6a94df237ee17f80122c8dc7 https://doi.org/10.1186/s12875-018-0846-y

Topics

Hypertension management

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Implication

This study protocol outlines a pragmatic trial to evaluate whether self-monitoring and self-titration of antihypertensive medication can improve blood pressure control in primary care.

Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Limitations

Cite This Study

Topics

Rationale and design of a pragmatic clinical trial to assess the impact of self-monitoring blood pressure at home and self-titration of antihypertensive medication in poorly controlled hypertension: the ADAMPA study protocol

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Limitations

Cite This Study

Also Consider

Topics

Also Consider