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

Not Applicable

Completed

• Conditions: Dyslipidemias
• Interventions: Behavioral: Pharmaceutical care plan

• Registration Number: NCT04319029
• Lead Sponsor: Al-Rasheed University College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Study First Posted: 2020-03-24
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Pharmaceutical care plan	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.

Primary Outcome Measures

Name	Time	Method
Change in the patient satisfaction	Baseline, and At 6 months	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	Baseline, at 3 months, and at 6 months	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	Baseline, and At 6 months	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	Baseline, and At 6 months	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

Name	Time	Method
Change in Serum LDL in intervention group vs. non-intervention group	Baseline, and At 6 months	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	Baseline, and At 6 months	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	Baseline, and At 6 months	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	Up to 6 months	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

Trial Locations

Locations (1)

Al-Rasheed University College; 🇮🇶 Baghdad, AL-Adhmia, Iraq