Assessment of Dyslipidemic Patients' Knowledge, Quality of Life, and Adherence

Dyslipidemias Clinical Trial

Official title:

Assessment of Patients' Knowledge, Quality of Life, and Adherence for Medication in Dyslipidemia - a Randomized Interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319029
• Other study ID #: AR190101
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: March 2020
• Source: Al-Rasheed University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

1. Pregnant women

2. Nephrotic syndrome

3. Active steroid user

4. Hypersensitivity for any mediation during the trial

5. History of a major cardiovascular event in the previous 3 months

6. Patients with mental disease or disability

7. Had a stroke in the previous 6 months

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Behavioral:
• Pharmaceutical care plan
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.

Locations

Country	Name	City	State
Iraq	Al-Rasheed University College	Baghdad	AL-Adhmia

Sponsors (1)

Lead Sponsor	Collaborator
Al-Rasheed University College

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, and At 6 months
Primary	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	Baseline, at 3 months, and at 6 months
Primary	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	Baseline, and At 6 months
Primary	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	Baseline, and At 6 months
Secondary	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	Baseline, and At 6 months
Secondary	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	Baseline, and At 6 months
Secondary	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	Baseline, and At 6 months
Secondary	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	Up to 6 months