DyslipidemiasNCT04319029
Assessment of Dyslipidemic Patients' Knowledge, Quality of Life, and Adherence
A study testing Pharmaceutical care plan in people with Dyslipidemias, run by Al-Rasheed University College at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Pharmaceutical care plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2018to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dyslipidemias
- Being tested
- Pharmaceutical care plan
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical care planBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pharmaceutical care plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, and At 6 months
Secondary outcomes (4)
Change in Serum LDL in intervention group vs. non-intervention group
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
Measured: Baseline, and At 6 months
Change in Serum HDL in intervention group vs. non-intervention group
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
Measured: Baseline, and At 6 months
Change in Serum cholesterol in intervention group vs. non-intervention group
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
Measured: Baseline, and At 6 months
Rate of Medication-related problems manged
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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Jan 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Rasheed University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hayder F Al-Tukmagi, PhD, Principal investigator, Al-Mustaffa University CollegeHayder A Fawzi, PhD, Study chair, Al-Rasheed University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319029
- Sponsor's protocol ID
- AR190101
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patients' Knowledge, Quality of Life, and Adherence for Medication in Dyslipidemia - a Randomized Interventional Study
- ClinicalTrials.gov ID
- NCT04319029
- Acronym / sponsor ID
- AR190101
- Conditions
- Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Rasheed University CollegeUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-intervention | No intervention | –Patients received a conventional pharmaceutical care plan, the patients offered optimal pharmacological therapy wit statin. |
| Intervention | Active comparator | Behavioral: Pharmaceutical care planThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaceutical care planThe 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. | Behavioural | Intervention |
Primary outcome
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
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
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
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
4 secondary outcomes
Change in Serum LDL in intervention group vs. non-intervention group
Time frame: 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 cholesterol in intervention group vs. non-intervention group
Time frame: Baseline, and At 6 months
Rate of Medication-related problems manged
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayder F Al-Tukmagi, PhD principal investigator
Al-Mustaffa University College
Hayder A Fawzi, PhD study chair
Al-Rasheed University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaceutical care plan in people with Dyslipidemias, run by Al-Rasheed University College at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the patient satisfaction (time frame: Baseline, and At 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.