Longer-term Effectiveness of Home Blood Pressure Self-monitoring Plus Self-titration of Antihypertensive Medication for Poorly Controlled Hypertension in Primary Care: An Extension of the ADAMPA Trial

Friday, August 26, 2022

5:45 PM – 5:50 PM CEST

Location: C1M2

Publication Number: 108

Background: Patient empowerment through pharmacological self-management is a common strategy in some chronic diseases such as diabetes, but it is rarely used for controlling BP. In the ADAMPA trial, self-monitoring plus self-titration showed promising results for reducing blood pressure at 12 months, without increasing healthcare utilization or adverse events.

Objectives: We extended the ADAMPA trial for up to 2 years (as planned) to evaluate the longer-term effectiveness of self-monitoring plus self-titration of antihypertensive medication versus usual care in poorly controlled hypertensive patients, with passive follow-up and primary-care nursing involvement.

Methods:

Design: The ADAMPA study was a pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms in Valencia, Spain; Participants: Hypertensive patients older than 40 years, with SBP over 145 mmHg and/or diastolic blood pressure (DBP) over 90 mmHg, recruited from July 2017 to June 2018; Intervention: Participants were randomized 1:1 to usual care versus an individualized, pre-arranged plan based on self-monitoring plus self-titration; Outcomes: The primary outcome was the adjusted mean difference (AMD) in SBP between groups at the end of follow-up. Secondary outcomes were: AMD in DBP, proportion of patients with optimal control, change in behaviours, quality of life, health services utilization and adverse events. Statistical analysis: Intention to treat analysis. A linear mixed-effects model was used to compare SBP between groups (as pre-specified). Differences in DBP were assessed using similar techniques. Stratified analyses of between-group MD in SBP were estimated. The ADAMPA was registered in clinicaltrials.gov (NCT03242785).

Results: Primary outcome data for the trial extension were available from 218 patients (intervention n=108, control n=111). Median follow-up was 23.5 months (IQR: 19.5-24.1 months). The AMD in SBP at the end of the follow-up (main analysis) was -3.4 mmHg (95%CI, -4.7 to -2.1, p< 0.001), while the AMD in DBP was -2.5 mmHg (95%CI, -3.5 to -1.6, p< 0.001). The subgroup analysis for the main outcome showed consistent results. However, a greater reduction was observed in patients with diabetes (MD -9.8 mmHg; 95% CI -18.2, -1.4; p = 0.024) and patients with diabetes and baseline SBP>=160 mmHg (MD -15.3 mmHg; 95% CI -28.5, -2.1; p = 0.025). No differences were observed in behaviours, quality of life, use of health services, or adverse events.

Conclusions: Self-monitoring plus self-titration of antihypertensive medication based on an individualized pre-arranged plan used in primary care reduced blood pressure in the longer-term with passive follow-up compared to usual care, without increasing healthcare utilization or adverse events.

Presenting Author(s)

Gabriel Sanfelix-Gimeno

Foundation for the Promotion of Health and Biomedical Research of Valencia Region
Valencia, Valencia, Spain

Slides

Co-Author(s)

PM

Patricia Martínez-Ibáñez

FISABIO, Spain
IM

Irene Marco-Moreno

FISABIO, Spain
CR

Celia Robles-Cabaniñas

FISABIO, Spain
EA

Eugenia Avelino-Hidalgo

INCLIVA, Spain
LB

Laura Bellot-Pujalte

INCLIVA, Spain
IB

Ignacio Barreira-Franch

INCLIVA, Spain
LM

Lucía Martínez-Ibáñez

INCLIVA, Spain
MG

Margarita Gimenez-Loreiro

INCLIVA, Spain
ME

Marina Escrig-Veses

INCLIVA, Spain
MC

Mercedes Calleja-Del-Ser

INCLIVA, Spain
MB

María Bóveda-Garcia

INCLIVA, Spain
CR

Clara Rodriguez-Bernal

Foundation for the Promotion of Health and Biomedical Research of the Valencia Region, Spain
Valencia, Comunidad Valenciana, Spain
IH

Isabel Hurtado

Foundation for the Promotion of Health and Biomedical Research of the Valencia Region, Spain, Spain
AG

Aníbal García-Sempere

FISABIO, Spain
SP

Salvador Peiró

FISABIO, Spain
JS

Jose Sanfélix-Genovés

FISABIO, Spain