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
| ISRCTN | ISRCTN21229328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21229328 |
| Secondary identifying numbers | PS09/01456 |
- Submission date
- 17/06/2010
- Registration date
- 27/07/2010
- Last edited
- 13/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Lucia Moreno
Scientific
Scientific
Gerencia de Atención Primaria
C/ Reina Esclaramunda nº 9
Palma de Mallorca
07003
Spain
| lmoreno@ibsalut.caib.es |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Mr Alfonso Leiva Rus [aleiva@ibsalut.caib.es] to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | The Ethical Committee on Human Reseach of Balearic Islands approved on the 26th May 2010 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/10/2010 |
| Completion date | 15/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 309 randomised patients from primary care centres in Spain |
| Key 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 |
| Key exclusion criteria | 1. Non-essential hypertensive patients 2. Haemodialysis patients 3. Institutionalised patients |
| Date of first enrolment | 15/10/2010 |
| Date of final enrolment | 15/12/2012 |
Locations
Countries of recruitment
- Spain
Study participating centre
Gerencia de Atención Primaria
Palma de Mallorca
07003
Spain
07003
Spain
Sponsor information
Health Service of the Balearic Islands (Servei de Salut de les Illes Balears [IB-salut]) (Spain)
Government
Government
Mallorca Primary Care Management
C/ Reina Esclaramunda nº 9
Palma de Mallorca
07003
Spain
| Phone | +34 (0)971 175883 |
|---|---|
| aleiva@ibsalut.caib.es | |
"ROR" |
https://ror.org/00d9y8h06 |
Funders
Funder type
Government
Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/09/2010 | Yes | No | |
| Other publications | resulst | 05/12/2014 | Yes | No |
