Cardiovascular Risk FactorsFAILAKANCT02096887
Effect of Patient Education on Compliance and Cardiovascular Risk Parameters
A study testing Patient Education in people with Cardiovascular Risk Factors, run by Kuwait Institute for Medical Specialization.
Trial summary
Patient's awareness of their risk factors for heart disease and their active involvement in their own management plan can help improve their adherence to treatment and their risk profile. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with one or more CVD risk factors will be consecutively enrolled, smokers and obese patients should have an additional risk factors
- The risk factors are based on Framingham Risk Score calculator and include smoking, high blood pressure, high blood cholesterol ,diabetes and being overweight or obese
- All participants must be adults (30 -70 years of age) who give an informed consent
- All participants should be of Kuwaity nationality, literate and fluent in either Arabic or English
- Patients are likely to be available for a one year follow up
Who cannot join
- Patients with mental disability or severe psychiatric disorder who are unable to provide informed consent or participate in educational activities.
- Patients with severe visual or hearing disability that will prevent participation in the educational activity
- Patients <30 years or >70 years of age
- Illiterate patients
- Non Kuwaity nationals
- Patients who are not permanently resident in Kuwait
- Patient who refuse to provide the informed consent
About this study
Official title: Effect of Patient Awareness and Education on Compliance and Cardiovascular Risk Factor Control
Patient's awareness of their risk factors for heart disease and their active involvement in their own management plan can help improve their adherence to treatment and their risk profile. The purpose of this study is to investigate the influence of patient education and awareness of heart disease risk factors on compliance to medication and lifestyle modification.
Read the detailed description
Prospective cluster randomized interventional study with primary health care clinics as clusters.Clinics will be randomized to conventional care or to structured patient education in addition to care. Trained physicians will extract information from the patient medical record and will conduct a personal interview with the participants, after they finish with their routine visit, to fill a case report form (CRF)
CRF will include the following items:
- Patient Demographics,
- Socioeconomic: income, employment and education
- Past Medical History
- Smoking history
- Alcohol use
- Medications
- Adherence: Morisky scale
- Examination: BP, weight, height, waist
- Investigations: LDL-C, HbA1C 2.Compliance/adherence to the medication will be measured by using the Morisky scale, which is a validated scale for measuring adherence in hypertension and diabetic patients among other disease.
Patients attending clinics that are randomized to structured patient education will receive education targeting all the risk factors they have. They will be informed about specific evidence -based target values they should achieve for each of the risk factors. Their compliance to prescribed medications will be encouraged and specific advice about improving compliance will be given. To achieve this physicians in the education clinics are going to use two items:
- Framingham Risk Score calculator.
- Know your numbers patient booklet.
Follow up visits will be scheduled at 2 months, 6 months and 12 months after the initial visit. For patients in both education and conventional clinics, compliance to medications will be assessed and the degree of risk factor control will also be determined through specific measurements that include number of cigarettes smoked, systolic and diastolic blood pressure, body mass index and waist circumference, HBA1C and LDL values.
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Patient Education
- Keywords
- education, compliance, risk factors
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationBehavioural
Patient Education using the following two instruments:
- Framingham Risk Score calculator:
- Know your numbers patient booklet
| Study group | Role | What they receive |
|---|---|---|
| Patient Education | Other | Patient Education Receives: Behavioral: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascualr risk factor control
Cardiovascular risk factors control as assessed by the following parameters: HbA1C, Blood pressure, LDL-C, BMI and smoking cessation
Measured: 12 months
medication compliance
Medication compliance as assessed by Morisky scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuwait Institute for Medical Specialization
- Sponsor type
- Other government
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Dr. Samia Almusallam, Kuwait Institute for Medical Specialization
- Investigators
- Samia Almusallam, FRCGP, Principal investigator, Kuwait Institute for Medical SpecializationMaleka M Serour, MRCGP/ INT, Principal investigator, Kuwait Institute for Medical SpecializationWafa A Rashed, FRCP, Principal investigator, Ministry of Health -Mubarak Hospital- Cardiology unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096887
- Sponsor's protocol ID
- WS964765
- Acronym
- FAILAKA
- Status last verified
- Mar 2014
- First submitted
- 24 Mar 2014
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Awareness and Education on Compliance and Cardiovascular Risk Factor Control
- ClinicalTrials.gov ID
- NCT02096887
- Acronym / sponsor ID
- FAILAKA / WS964765
- Conditions
- Cardiovascular Risk Factors
- Keywords
- education, compliance, risk factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Kuwait Institute for Medical SpecializationOther government
- Collaborators
- Pfizer
- Study start
- Jun 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient's awareness of their risk factors for heart disease and their active involvement in their own management plan can help improve their adherence to treatment and their risk profile. The purpose of this study is to investigate the influence of patient education and awareness of heart disease risk factors on compliance to medication and lifestyle modification.
Detailed description
Prospective cluster randomized interventional study with primary health care clinics as clusters.Clinics will be randomized to conventional care or to structured patient education in addition to care. Trained physicians will extract information from the patient medical record and will conduct a personal interview with the participants, after they finish with their routine visit, to fill a case report form (CRF)
CRF will include the following items:
- Patient Demographics,
- Socioeconomic: income, employment and education
- Past Medical History
- Smoking history
- Alcohol use
- Medications
- Adherence: Morisky scale
- Examination: BP, weight, height, waist
- Investigations: LDL-C, HbA1C 2.Compliance/adherence to the medication will be measured by using the Morisky scale, which is a validated scale for measuring adherence in hypertension and diabetic patients among other disease.
Patients attending clinics that are randomized to structured patient education will receive education targeting all the risk factors they have. They will be informed about specific evidence -based target values they should achieve for each of the risk factors. Their compliance to prescribed medications will be encouraged and specific advice about improving compliance will be given. To achieve this physicians in the education clinics are going to use two items:
- Framingham Risk Score calculator.
- Know your numbers patient booklet.
Follow up visits will be scheduled at 2 months, 6 months and 12 months after the initial visit. For patients in both education and conventional clinics, compliance to medications will be assessed and the degree of risk factor control will also be determined through specific measurements that include number of cigarettes smoked, systolic and diastolic blood pressure, body mass index and waist circumference, HBA1C and LDL values.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Education | Other | Behavioral: Patient EducationPatient Education |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with one or more CVD risk factors will be consecutively enrolled, smokers and obese patients should have an additional risk factors
- The risk factors are based on Framingham Risk Score calculator and include smoking, high blood pressure, high blood cholesterol ,diabetes and being overweight or obese
- All participants must be adults (30 -70 years of age) who give an informed consent
- All participants should be of Kuwaity nationality, literate and fluent in either Arabic or English
- Patients are likely to be available for a one year follow up
Key exclusion criteria (7 listed)
- Patients with mental disability or severe psychiatric disorder who are unable to provide informed consent or participate in educational activities.
- Patients with severe visual or hearing disability that will prevent participation in the educational activity
- Patients <30 years or >70 years of age
- Illiterate patients
- Non Kuwaity nationals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient EducationPatient Education using the following two instruments: 1. Framingham Risk Score calculator: 2. Know your numbers patient booklet | Behavioural | Patient Education |
Primary outcome
cardiovascualr risk factor control
Time frame: 12 months
Cardiovascular risk factors control as assessed by the following parameters: HbA1C, Blood pressure, LDL-C, BMI and smoking cessation
medication compliance
Time frame: 12 months
Medication compliance as assessed by Morisky scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
Related trials for Cardiovascular Risk Factors
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
Heart Failure, Cardiovascular Risk Factors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samia Almusallam, FRCGP principal investigator
Kuwait Institute for Medical Specialization
Maleka M Serour, MRCGP/ INT principal investigator
Kuwait Institute for Medical Specialization
Wafa A Rashed, FRCP principal investigator
Ministry of Health -Mubarak Hospital- Cardiology unit
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education in people with Cardiovascular Risk Factors, run by Kuwait Institute for Medical Specialization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascualr risk factor control (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.