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Completed

NCT Number: NCT04319029

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

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.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Rasheed University College

Baghdad, AL-Adhmia, 12221, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmaceutical care plan

Behavioral

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 outcomes

  1. Change in the patient satisfaction

    Time frame: 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

  2. Change in the medication adherence in intervention group vs. non-intervention group

    Time frame: 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

  3. Change in the hyperlipidemia-Patient Knowledge in intervention group vs. non-intervention group

    Time frame: 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

  4. Change in the quality of life in intervention group vs. non-intervention group

    Time frame: 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 outcomes

  1. Change in Serum LDL in intervention group vs. non-intervention group

    Time frame: 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

  2. Change in Serum HDL in intervention group vs. non-intervention group

    Time frame: 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

  3. Change in Serum cholesterol in intervention group vs. non-intervention group

    Time frame: 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

  4. Rate of Medication-related problems manged

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Al-Rasheed University College

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 24, 2020
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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