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

N/ACompletedNCT04319029

Al-Rasheed University College50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Dyslipidemias

Interventions

Pharmaceutical care planBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Al-Rasheed University College

Baghdad, AL-Adhmia, Iraq

Outcomes

Primary Outcomes

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

Time frame: Baseline, and At 6 months

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

Time frame: Baseline, at 3 months, and at 6 months

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

Time frame: Baseline, and At 6 months

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

Time frame: Baseline, and At 6 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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