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

March 23, 2020 updated by: Al-Rasheed University College

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • AL-Adhmia
      • Baghdad, AL-Adhmia, Iraq, 12221
        • Al-Rasheed University College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, and At 6 months
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
Baseline, at 3 months, and at 6 months
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
Baseline, and At 6 months
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
Baseline, and At 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, and At 6 months
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
Baseline, and At 6 months
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
Baseline, and At 6 months
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
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Rasheed University College

Investigators

  • Principal Investigator: Hayder F Al-Tukmagi, PhD, Al-Mustaffa University College
  • Study Chair: Hayder A Fawzi, PhD, Al-Rasheed University College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

March 13, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (ACTUAL)

March 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR190101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Starting after the publication of the research

IPD Sharing Access Criteria

Any interested Party

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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