|- candidate number||21634|
|- NTR Number||NTR5017|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-feb-2015|
|- Secondary IDs||WC2015-019 VUmc |
|- Public Title||Cardiovascular non-Adherence Tailored Intervention (CATI) care programme |
|- Scientific Title||Randomized controlled trial to test the (cost)-effectiveness of a patient tailored intervention programme (CATI) to enhance
adherence to cardiovascular medication
|- ACRONYM||CATI care programme|
|- hypothesis||In this project the hypothesis is tested that the community pharmacist-led CATI care programme in patients using cardiovascular medication, will have a beneficial effect on patients’ adherence to cardiovascular medication and improves clinical parameters, and is cost-effective|
|- Healt Condition(s) or Problem(s) studied||Compliance, Cardiovascular disease, Medication adherence|
|- Inclusion criteria||1) Age 45-75 years |
2) Using cardiovascular medication i.e. antihypertensive and/or lipid-lowering drugs
3) Meeting all three inclusion criteria described below:
a. Being refill non-adherent according to pharmacy dispensing data
b. Being non-adherent according to a self-report questionnaire
c. Having abnormal clinical rates to low-density lipoprotein concentration and/or blood pressure
|- Exclusion criteria||1) Being unable to speak or read Dutch|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2013|
|- planned closingdate||30-nov-2017|
|- Target number of participants||176|
|- Interventions||The CATI care programme is a patient tailored intervention programme to enhance adherence to cardiovascular medication, incorporating the identification of barriers for non-adherence and offering interventions tailored to the specific needs of the patient. The programme will be executed by the pharmacist and consist of different components. |
The pharmacist asks the patients to participate in the CATI care programme and invites them for a medication interview in the pharmacy.
• Quick Barrier Scan
The pharmacist interviews the patients according to a semi-structured interview guide, called the Quick Barrier Scan. The aim of the interview is to explore the patient’s barriers and problems to adhere to the medication. Based on the answers of the patient, the patient can be classified into a ‘barrier profile’. The Quick Barrier Scan incorporates five to six different ‘barrier profiles’.
• Tailored Intervention Guide
The results of the Quick Barrier Scan will be evaluated by the pharmacist. A ‘barrier profile’ will be assigned and appropriate interventions will be selected from the Tailored Intervention Guide. The Tailored Intervention Guide provides an overview with the best suited interventions corresponding to the patients’ ‘barrier profile’. For example:
Barrier profile A = intervention 1a or 1b
Barrier profile B = intervention 2
Barrier profile C = intervention 3a or 3a
Examples of possible interventions are: addressing side-effects, for instance by performing a medication review; improving knowledge, for instance about the use and effectiveness of the medication; or providing tools, for instance reminder services and pillboxes.
• Consultation upon initiation
The pharmacist invites the patient to the pharmacy. According to the ‘shared decision making’ approach, the pharmacist and patient decide which intervention to start and how to execute the intervention. The pharmacist will introduce and explain different options for interventions and the patient will be supported in exploring his/her preferences and choosing an intervention. By means of this approach each patient explores what most matters to him/her.
• Telephonic follow-up consultation
Between three and four months after the start of the intervention, the pharmacist will contact the patient for a telephonic follow-up consultation.
|- Primary outcome||Self-reported medication adherence is the primary outcome measure. Medication adherence will be assessed at baseline, at follow-up and at endline. Differences between the medication non-adherence at baseline and at endline will be compared. Medication adherence will be assessed with the MARS-5 questionnaire.|
|- Secondary outcome||LDL concentration and BP are clinical secondary outcome measures. The pre-measurement will be included in the selection procedure at baseline and the post-measurement will be assessed after six months. LDL concentration will be measured with a finger prick of blood. Blood pressure will be measured with a sphygmomanometer. |
Quality of life will be assessed by using the Short Form 12 Health Survey (SF-12) questionnaire. The SF-12 questionnaire consists of 12 questions covering eight dimension of health i.e. general health perception, physical functioning, limitations due to physical health problems, bodily pain, vitality, social functioning, emotional functioning and general mental health. The eight domains can produce two summary scores for physical health (Physical Component Score, PCS) and mental health (Mental Component Score, MCS).
|- Timepoints||0, 3 and 6 months|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Danielle van der Laan|
|- CONTACT for SCIENTIFIC QUERIES|| Danielle van der Laan|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Royal Dutch Pharmacists Association|
|- Brief summary||Cardiovascular disease is a chronic condition, characterized by high mortality and morbidity. Due to inadequately following cardiovascular pharmacological treatment plans, i.e. medication non-adherence, substantial numbers of cardiovascular patients benefit from their medication to a limited extent. Non-adherence is influenced by patient-, social and economic-, condition-, therapy-, healthcare team and system-related factors.|
A multi-centre, randomized controlled trial will be performed in 11 community pharmacies, including 176 patients. Patients aged 45–75 years using cardiovascular medication, i.e. antihypertensive and/or lipid-lowering drugs are eligible to participate. Patients must be non-adherent in refilling medication, must be non-adherent measured with a self-report questionnaire and must have at least one abnormal clinical parameters i.e. a high low-density lipoprotein concentration and a high blood pressure. Patients in the intervention group will receive a patient tailored intervention, called the CATI care programme. The CATI care programme is a patient tailored intervention programme to enhance adherence to cardiovascular medication, incorporating the identification of barriers for non-adherence and offering interventions tailored to the specific needs of the patient. The programme will be executed by the pharmacist and consist of different components.
The primary outcome is self-reported medication adherence. Secondary outcome measures are measured clinical parameters and quality of life.
|- Main changes (audit trail)|
|- RECORD||2-feb-2015 - 11-apr-2015|