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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319029
Recruitment Status : Completed
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Behavioral: Pharmaceutical care plan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessment of Patients' Knowledge, Quality of Life, and Adherence for Medication in Dyslipidemia - a Randomized Interventional Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Arm Intervention/treatment
No Intervention: Non-intervention
Patients received a conventional pharmaceutical care plan, the patients offered optimal pharmacological therapy wit statin.
Active Comparator: Intervention
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.
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.





Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319029


Locations
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Iraq
Al-Rasheed University College
Baghdad, AL-Adhmia, Iraq, 12221
Sponsors and Collaborators
Al-Rasheed University College
Investigators
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Principal Investigator: Hayder F Al-Tukmagi, PhD Al-Mustaffa University College
Study Chair: Hayder A Fawzi, PhD Al-Rasheed University College
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Responsible Party: Al-Rasheed University College
ClinicalTrials.gov Identifier: NCT04319029    
Other Study ID Numbers: AR190101
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Starting after the publication of the research
Access Criteria: Any interested Party

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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
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases