Condition category
Circulatory System
Date applied
17/06/2010
Date assigned
27/07/2010
Last edited
13/01/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Lucia Moreno

ORCID ID

Contact details

Gerencia de Atención Primaria
C/ Reina Esclaramunda nº 9
Palma de Mallorca
07003
Spain
-
lmoreno@ibsalut.caib.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PS09/01456

Study information

Scientific title

A randomised controlled trial on the efficacy of a multifactorial intervention to improve adherence to treatment for systolic blood pressure (BP) reduction in primary care patients with poorly controlled or uncontrolled BP

Acronym

Study hypothesis

Background:
Lowering blood pressure (BP) with antihypertensive drugs has an important risk reduction effect on cardiovascular events, mainly stroke and total mortality. However lack of adherence to antihypertensive medication reduces its effectiveness and increases the risk for adverse effects to the medication. Improvement of patient adherence to the treatment could be similar in relative risk reduction than the development of a new drug.

Hypotheses:
1. In primary care patients with poorly- or un-controlled BP and low adherence to treatment, a 9-month multifactorial intervention with the aim of improving communication between medical staff and patient and thus facilitating the taking of medication will result in decreased systolic blood pressure (SBP) at 12 months compared with patients in the control group
2. The estimated direct cost at 12 months resulting from the use of health services associated with hypertension in the intervention group will be at least 10% lower than the control group
3. The number needed to treat (NNT) will be 10 - 15

Please note that as of 16/01/2013, the following changes were made to the record:
1. The public title was previously "Clinical trial on the efficacy of an intervention package to improve adherence to treatment for systolic blood pressure (BP) reduction in primary care patients with poorly controlled or uncontrolled BP and low adherence to treatment"
2. The scientific title was previously "A randomised controlled trial on the efficacy of a multifactorial intervention to improve adherence to treatment for systolic blood pressure (BP) reduction in primary care patients with poorly controlled or uncontrolled BP and low adherence to treatment"

Ethics approval

The Ethical Committee on Human Reseach of Balearic Islands approved on the 26th May 2010

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Mr Alfonso Leiva Rus [aleiva@ibsalut.caib.es] to request a patient information sheet

Condition

Non-optimally controlled hypertension

Intervention

Patients in the intervention group will attend of 3 sessions consisting of a 30 minute semi-structured motivational interview and a 15-minute health education programme combined with simplifying dosing regimens, family and/or social support, blood pressure self-monitoring and use of medication reminders.

Patients in the control group will receive treatment as usual.

The duration of the intervention will be 6 months. The total duration of follow-up will be 12 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in systolic BP at 12 months

Secondary outcome measures

1. Change in diastolic BP
2. Proportion of participants with adequate BP control at 12 months
3. Total direct cost

Overall trial start date

15/10/2010

Overall trial end date

15/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 16/01/2013:
1. Patients between 18 and 80 years of age
2. Non controlled BP according to European Societies of Hypertension and Cardiology (ESH/ESC) guidelines (i.e. BP less than 140/90 mmHg or less than 130/80 mmHg in diabetic or renal failure patients)

Previous inclusion criteria until 16/01/2013:
1. Patients between 18 and 80 years of age
2. Non controlled BP according to European Societies of Hypertension and Cardiology (ESH/ESC) guidelines (i.e. BP less than 140/90 mmHg or less than 130/80 mmHg in diabetic or renal failure patients)
3. Adherence below 80% to AHT by Hayness-Sacket Test

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

309 randomised patients from primary care centres in Spain

Participant exclusion criteria

1. Non-essential hypertensive patients
2. Haemodialysis patients
3. Institutionalised patients

Recruitment start date

15/10/2010

Recruitment end date

15/12/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Gerencia de Atención Primaria
Palma de Mallorca
07003
Spain

Sponsor information

Organisation

Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)

Sponsor details

Mallorca Primary Care Management
C/ Reina Esclaramunda nº 9
Palma de Mallorca
07003
Spain
+34 (0)971 175883
aleiva@ibsalut.caib.es

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20868531
2014 resulst in: http://www.ncbi.nlm.nih.gov/pubmed/25525344

Publication citations

  1. Results

    Leiva A, Fajó M, Escriche L, Audera FJ, López S, Martín MC, González R, Tamborero G, García EM, Duro R, Orueta R, Serra F, D'agosto P P, Miralles J, Lorente P, Llobera J, Iglesias AA, Fernández R, Colom MM, Buades AM, Moreno L, Vidal C, , Efficacy of a brief multifactorial adherence-based intervention on reducing the blood pressure of patients with poor adherence: protocol for a randomized clinical trial., BMC Cardiovasc Disord, 2010, 10, 44, doi: 10.1186/1471-2261-10-44.

  2. Results

    Leiva A, Aguiló A, Fajó-Pascual M, Moreno L, Martín MC, Garcia EM, Duro RE, Serra F, Dagosto P, Iglesias-Iglesias AA, Company RM, Yañez A, Llobera J, Efficacy of a brief multifactorial adherence-based intervention in reducing blood pressure: a randomized clinical trial, Patient Prefer Adherence, 2014, 8, 1683-1690, doi: 10.2147/PPA.S66927.

Additional files

Editorial Notes