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ISRCTN
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ISRCTN21229328
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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PS09/01456
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Study hypothesis
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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
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Lay summary
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Ethics approval
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The Ethical Committee on Human Reseach of Balearic Islands approved on the 26th May 2010
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Study design
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Cluster randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Non-optimally controlled hypertension
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Non-essential hypertensive patients
2. Haemodialysis patients
3. Institutionalised patients
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Anticipated start date
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15/10/2010
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Anticipated end date
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15/12/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please contact Mr Alfonso Leiva Rus [aleiva@ibsalut.caib.es] to request a patient information sheet
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Target number of participants
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309 randomised patients from primary care centres in Spain
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Interventions
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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.
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Primary outcome measure(s)
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Change in systolic BP at 12 months
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Secondary outcome measure(s)
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1. Change in diastolic BP
2. Proportion of participants with adequate BP control at 12 months
3. Total direct cost
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Sources of funding
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Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (Spain)
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20868531
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Contact name
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Miss
Lucia
Moreno
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Address
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Gerencia de Atención Primaria
C/ Reina Esclaramunda nº 9
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City/town
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Palma de Mallorca
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Zip/Postcode
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07003
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Country
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Spain
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Email
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lmoreno@ibsalut.caib.es
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Sponsor
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Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)
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Address
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Mallorca Primary Care Management
C/ Reina Esclaramunda nº 9
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City/town
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Palma de Mallorca
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Zip/Postcode
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07003
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Country
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Spain
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Tel
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+34 (0)971 175883
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Fax
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+34 (0)971 175888
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Email
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aleiva@ibsalut.caib.es
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Date applied
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17/06/2010
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Last edited
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26/05/2011
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Date ISRCTN assigned
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27/07/2010
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