Primary objective of this study is to improve medication adherence by introduction of adequate screening methods and an additional specific nurse based intervention (structural informative consulting and motivational counseling) in combination with…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of non-adherent patients with improvement of adherence after
specific intervention.The results of the refill records of computerized
pharmacy systems evaluation will be used as gold standerd for medication
adherence.
Secondary outcome
Determination of best applicable method for current adherence and risk of
non-adherence in usual cardiovascular preventive care by comparing the results
of the MMS and the BMQ with refill records of computerized pharmacy systems.
Determination of most effective and best applicable intervention to improve
adherence or prevent decline in adherence in cardiovascular patients, by
evaluation combinations of regular care, web based visualization and support
and/or nurse-based intervention with refill records of computerized pharmacy
systems.
Background summary
Poor adherence to medicines is one of the limitations in the treatment of
cardiovascular disease.
According to WHO takes only 50% of patients with a chronic illness takes its
medication as prescribed. Approximately 25-50% of patients stops taking their
medication within one year after starting treatment. The consequences are an
increased risk of premature death, hospital admissions and related costs. The
dedection of a poor adherence is of great importance to provide adequate
interventions in time.In this study the adherence data of all patients within
the hospital-wide cardiovascular prevention project, will be requested at their
pharmacy. The effect of a structured communication intervention by a nurse and
an intervention by the interactive website vascular care (iVAZ) in the therapy
of statins, will be explored in a randomized study.
Study objective
Primary objective of this study is to improve medication adherence by
introduction of adequate screening methods and an additional specific nurse
based intervention (structural informative consulting and motivational
counseling) in combination with personalized visualization of cardiovascular
risk levels (website) in cardiovascular patients.
Secondary objectives are:
1) Evaluation of best applicable screening method for current adherence and
risk of non-adherence (combinations of health status, motivation to change,
prescribed therapy, and/or BMQ, MMS and refill records results) in usual
cardiovascular preventive care.
2) Evaluation of most effective and best applicable intervention (combinations
of regular care, web based visualisation and support and/or nurse-based
intervention) to improve adherence or prevent decline in adherence in
cardiovascular patients
Study design
It is a prospective, randomized study comparing the effect of an intervention
by a communication nurse and the effect of an intervention by the interactive
patient portal. These will be compared to the usual care. Patients will be
randomly randomized (1:1:1) in either a group with regular care (group I) or a
group with regular care including access to website (iVAZ) to be informed about
their cardiovascular risk (group II) or a group with access to the website
(iVAZ) and referring to nurse-based interventions to improve adherence (group
III) on top of regular care.
During a period of 6 months, 600 successive patients visiting the outpatient
clinic for secondary prevention will be randomized for this study. All patients
will be regularly screened according to the hospital screening program
including an automated lifestyle questionnaire, which will include the MMS and
BMQ, regular medication use will be recorded. As part of the screening, blood
lipid levels (total cholesterol, triglycerides, HDL-C and LDL-C) will be
determined. The screening also includes: Blood pressure, waist circumference
(wc), BMI, blood level of glucose and a family history for cardiovascular
diseases.
After 12 months from baseline a regular evaluation of the cardiovascular risk
profile, including the automated lifestyle questionnaire and the MMS and the
BMQ will be performed to all three groups.
Simultaneously, data of refill records of the pharmacys of all patients will be
collected by a computerized system to adequately register changes in
adherence.
Intervention
Group II + III will get access to web portal (iVAZ) to see their cardiovascular
risk level. On 12 weeks and 10 months for the groups II+III their lipid level,
blood pressure, BMI and waist circumference will be determined and made visual
on iVAZ. Group III will also have group- and individual consultation on 9 and
12 weeks and 10 months.
The group- and individual consultation is a structured communication
intervention carried out by a nurse, consisting a group consultation and three
one-on-one contacts between nurse and patient. Communication strategies in
these consultations by means of a literature study and observation of other
practices in the UMC St.Radboud already proved successful (eg approach smoking,
obesity) will be explored. These are strategies such as
- Positive reward strategies,
- Enabling the network of the patient,
- Discussion group / consultation with peers,
- Use of specific interview techniques by the nurse (in understandable
language, consistent with the level and knowledge of the patient)
After 12 months all patients (usual care):
re-determination of their cholesterol, blood pressure, BMI and medication .
Study burden and risks
1) Intervention
Both intervention groups will have to go to the hospital three to four times.
The interventiongroup (viualization of cholesterollevels in a risk meter) will
have to come three times to the hospital.The cholesterol will be determined
through a vein punction.
The intervention group + will also recieve1x60 minutes (group consultation) and
3x 20 minutes consultation with a nurse at the hospital.
There is no risk associated with participation
Geert Groteplein 10
6500 HB Nijmegen
NL
Geert Groteplein 10
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Cardiovascular patients with indication for secundary cardiovascular prevention, best medical treatment
Exclusion criteria
Pregnancy
Age below age of 18years
No Dutch speaking
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL34338.091.11 |