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
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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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20868531
2014 resulst in: http://www.ncbi.nlm.nih.gov/pubmed/25525344
Publication citations
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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.
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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.