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

NCT04319029 | Completed DMC

• 1 other identifier: AR190101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Baseline, and At 6 months

Secondary Outcomes (4)

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

  Baseline, and At 6 months

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

  Baseline, and At 6 months

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

  Baseline, and At 6 months

• Rate of Medication-related problems manged

  Up to 6 months

Study Arms (2)

Non-intervention

NO INTERVENTION

Patients received a conventional pharmaceutical care plan, the patients offered optimal pharmacological therapy wit statin.

Intervention

ACTIVE COMPARATOR

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Rasheed University College: lead

Study Sites (1)

Al-Rasheed University College

Baghdad, AL-Adhmia, 12221, Iraq

Location

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hayder F Al-Tukmagi, PhD

  Al-Mustaffa University College

  PRINCIPAL INVESTIGATOR

• Hayder A Fawzi, PhD

  Al-Rasheed University College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 24, 2020
• Study Start: January 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Starting after the publication of the research
• Access Criteria: Any interested Party

Locations

IR (1)