Assessment of Dyslipidemic Patients' Knowledge, Quality of Life, and Adherence
Primary Purpose
Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Pharmaceutical care plan
Sponsored by
About this trial
This is an interventional supportive care trial for Dyslipidemias
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with dyslipidemia and received at least one statin therapy (in the previous 6 months), and patients on the same class of pharmacological therapy (statins).
Exclusion Criteria:
- Pregnant women
- Nephrotic syndrome
- Active steroid user
- Hypersensitivity for any mediation during the trial
- History of a major cardiovascular event in the previous 3 months
- Patients with mental disease or disability
- Had a stroke in the previous 6 months
Sites / Locations
- Al-Rasheed University College
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Non-intervention
Intervention
Arm Description
Patients received a conventional pharmaceutical care plan, the patients offered optimal pharmacological therapy wit statin.
The Patients offered to predesign pharmaceutical care plans aimed to improved patient's knowledge, adherence, satisfaction, and quality of life. The patients offered optimal pharmacological therapy wit statin.
Outcomes
Primary Outcome Measures
Change in the patient satisfaction
Pharmaceutical Care Satisfaction Questionnaire (PCSQ) score for patient satisfaction:
A 30-items score each item composed of a 5-point Likert scale (5 = strongly agree and 1 = strongly disagree), then the items are averaged and presented (value between 1 - 5) Unit of Measure is units on a Scale of 5
Change in the medication adherence in intervention group vs. non-intervention group
Visual Analogue Scale (VAS) for medication adherence:
The participants will be asked to mark a line at the point along a continuum showing how much of each drug they have taken in the past month, this scare take range from 0 - 10.
Unit of Measure is units on a Scale of 10
Change in the hyperlipidemia-Patient Knowledge in intervention group vs. non-intervention group
Hyperlipidemia-Patient Knowledge Evaluation score:
The Hyperlipidemia-Patient Knowledge Evaluation is a 17-item true-or-false questionnaire, which involved general knowledge, habit, diet, pharmacotherapy, and complications. The score ranges from 0 - 16.
Unit of Measure is units on a Scale of 16
Change in the quality of life in intervention group vs. non-intervention group
The RAND 36-items score (SF-36) for quality of life (QoL):
This score composed of 36-items that contain 8 domains, the score has a range from 0 - 100 which represents the average of these domains.
Unit of Measure is units on a Scale of 100
Secondary Outcome Measures
Change in Serum LDL in intervention group vs. non-intervention group
Change in serum LDL that will occur in both the intervention group and non-intervention group, and determine which group will provide a more significant reduction in serum LDL.
Unit of Measure is mg/dL
Change in Serum HDL in intervention group vs. non-intervention group
Change in serum HDL that will occur in both the intervention group and non-intervention group, and determine which group will provide a more significant reduction in serum HDL.
Unit of Measure is mg/dL
Change in Serum cholesterol in intervention group vs. non-intervention group
Change in serum cholesterol that will occur in both the intervention group and non-intervention group, and determine which group will provide a more significant reduction in serum HDL.
Unit of Measure is mg/dL
Rate of Medication-related problems manged
Each successful management of medication-related problems reported by the patients by the pharmacist will be recorded and compared between the intervention group vs. non-intervention group Unit of measure is the percentage
Full Information
NCT ID
NCT04319029
First Posted
March 13, 2020
Last Updated
March 23, 2020
Sponsor
Al-Rasheed University College
1. Study Identification
Unique Protocol Identification Number
NCT04319029
Brief Title
Assessment of Dyslipidemic Patients' Knowledge, Quality of Life, and Adherence
Official Title
Assessment of Patients' Knowledge, Quality of Life, and Adherence for Medication in Dyslipidemia - a Randomized Interventional Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Al-Rasheed University College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized, parallel two-arm interventional study, the patients were divided into 1:1 ratio, in which both groups offered optimal pharmacological therapy also one group (interventional) offered predesign pharmaceutical care plan aimed to improved patients knowledge, adherence, satisfaction, and quality of life, while the other group (non-interventional) received conventional pharmaceutical care plan.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-intervention
Arm Type
No Intervention
Arm Description
Patients received a conventional pharmaceutical care plan, the patients offered optimal pharmacological therapy wit statin.
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
The Patients offered to predesign pharmaceutical care plans aimed to improved patient's knowledge, adherence, satisfaction, and quality of life. The patients offered optimal pharmacological therapy wit statin.
Intervention Type
Behavioral
Intervention Name(s)
Pharmaceutical care plan
Intervention Description
The design of the intervention was based on a stepwise approach to address the following point in each participant: set priorities for patient care, assessment of patient's educational needs, and development of a comprehensive and achievable pharmaceutical care plan.
The participants will be educated about their illness and informed about the proper use of their medication in a structured manner (it involved the following items: dyslipidemia as a disease, complications, who therapy reduces its risk and complications, goal of therapy). Behavioral modifications will involve the following: physical exercise, diet, smoking cessation. Patients will obtain this information verbally and provided in a written manner through a brochure that design for this study.
Primary Outcome Measure Information:
Title
Change in the patient satisfaction
Description
Pharmaceutical Care Satisfaction Questionnaire (PCSQ) score for patient satisfaction:
A 30-items score each item composed of a 5-point Likert scale (5 = strongly agree and 1 = strongly disagree), then the items are averaged and presented (value between 1 - 5) Unit of Measure is units on a Scale of 5
Time Frame
Baseline, and At 6 months
Title
Change in the medication adherence in intervention group vs. non-intervention group
Description
Visual Analogue Scale (VAS) for medication adherence:
The participants will be asked to mark a line at the point along a continuum showing how much of each drug they have taken in the past month, this scare take range from 0 - 10.
Unit of Measure is units on a Scale of 10
Time Frame
Baseline, at 3 months, and at 6 months
Title
Change in the hyperlipidemia-Patient Knowledge in intervention group vs. non-intervention group
Description
Hyperlipidemia-Patient Knowledge Evaluation score:
The Hyperlipidemia-Patient Knowledge Evaluation is a 17-item true-or-false questionnaire, which involved general knowledge, habit, diet, pharmacotherapy, and complications. The score ranges from 0 - 16.
Unit of Measure is units on a Scale of 16
Time Frame
Baseline, and At 6 months
Title
Change in the quality of life in intervention group vs. non-intervention group
Description
The RAND 36-items score (SF-36) for quality of life (QoL):
This score composed of 36-items that contain 8 domains, the score has a range from 0 - 100 which represents the average of these domains.
Unit of Measure is units on a Scale of 100
Time Frame
Baseline, and At 6 months
Secondary Outcome Measure Information:
Title
Change in Serum LDL in intervention group vs. non-intervention group
Description
Change in serum LDL that will occur in both the intervention group and non-intervention group, and determine which group will provide a more significant reduction in serum LDL.
Unit of Measure is mg/dL
Time Frame
Baseline, and At 6 months
Title
Change in Serum HDL in intervention group vs. non-intervention group
Description
Change in serum HDL that will occur in both the intervention group and non-intervention group, and determine which group will provide a more significant reduction in serum HDL.
Unit of Measure is mg/dL
Time Frame
Baseline, and At 6 months
Title
Change in Serum cholesterol in intervention group vs. non-intervention group
Description
Change in serum cholesterol that will occur in both the intervention group and non-intervention group, and determine which group will provide a more significant reduction in serum HDL.
Unit of Measure is mg/dL
Time Frame
Baseline, and At 6 months
Title
Rate of Medication-related problems manged
Description
Each successful management of medication-related problems reported by the patients by the pharmacist will be recorded and compared between the intervention group vs. non-intervention group Unit of measure is the percentage
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with dyslipidemia and received at least one statin therapy (in the previous 6 months), and patients on the same class of pharmacological therapy (statins).
Exclusion Criteria:
Pregnant women
Nephrotic syndrome
Active steroid user
Hypersensitivity for any mediation during the trial
History of a major cardiovascular event in the previous 3 months
Patients with mental disease or disability
Had a stroke in the previous 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayder F Al-Tukmagi, PhD
Organizational Affiliation
Al-Mustaffa University College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hayder A Fawzi, PhD
Organizational Affiliation
Al-Rasheed University College
Official's Role
Study Chair
Facility Information:
Facility Name
Al-Rasheed University College
City
Baghdad
State/Province
AL-Adhmia
ZIP/Postal Code
12221
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
Starting after the publication of the research
IPD Sharing Access Criteria
Any interested Party
Learn more about this trial
Assessment of Dyslipidemic Patients' Knowledge, Quality of Life, and Adherence
We'll reach out to this number within 24 hrs