Acute Coronary SyndromeNCT02922140
The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit
A study testing pharmaceutical care service in people with Acute Coronary Syndrome, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to investigate the role of clinical pharmacist in the development of a pharmaceutical care program for patients with Acute coronary syndrome tailored to their specific learning needs and their cultural context, and to verify the program's effects on physiological factors and recurrent symptoms or… Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- pharmaceutical care service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Aug 2017
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are diagnosed with Acute coronary syndrome (ischemic heart disease) by their primary cardiologist, treated with medication, percutaneous coronary angioplasty, or coronary artery bypass graft.
- At 20-79 years of age.
- Has the ability to perform regular physical activity according to the patients' self-identification and the judgment of their primary cardiologist.
- Willing to participate in this study.
- Able to be reached by telephone postdischarge.
Who cannot join
- Patients with cognitive impairment.
- If they need professional help to take their medication at home.
- With terminal illness.
- Inability to communicate.
- Severe arrhythmia.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the role of clinical pharmacist in the development of a pharmaceutical care program for patients with Acute coronary syndrome tailored to their specific learning needs and their cultural context, and to verify the program's effects on physiological factors and recurrent symptoms or cardiac events.
- Conditions
- Acute Coronary Syndrome
- Being tested
- pharmaceutical care service
- Keywords
- pharmaceutical care service, clinical pharmacist, Cardiac rehabilitation unit, Acute coronary syndrome, patient education and counselling
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical care serviceBehavioural
Also called pharmaceutical care plan, Comprehensive health care services
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | will receive standard care by physician in attendance |
| intervention group | Active comparator | will be supplied by clinical pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance. Receives: Behavioral: pharmaceutical care service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of patient education about disease, drugs and lifestyle modification using coronary artery disease education questionnaire (CADE-Q)
at baseline and after three months
Measured: three months
Change in the number of solved drug-related problems
assessment of drug-related problems at baseline and solving them during three months
Measured: three months
Assessment of medications adherence: (Eight-item Morisky adherence questionnaire).
at baseline and after three months
Measured: three months
Secondary outcomes (6)
Assessment of quality of life: (36-items self-care Health survey (SF-36)).
at baseline and after three months
Measured: three months
Assessment of smoker's dependence on cigarette smoking: (using the Fagerstrom Test for Nicotine Dependence).
at baseline and after three months
Measured: three months
Change in heart rate [HR] (Bpm).
at baseline and after three months
Measured: three months
Change in Lipid profile : total cholesterol (mg/dl), triglycerides(mg/dl), and low density lipoprotein cholesterol(mg/dl), high density lipoprotein (mg/dl)
at baseline and after three months
Measured: three months
Change in levels of fasting blood glucose (mg/dl)
at baseline and after three months
Measured: three months
Change in systolic and diastolic blood pressure [BP] (mmHg).
at baseline and after three months
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, eman ahmed el-said casper, Ain Shams University
- Investigators
- Eman A. Casper, bachelor, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922140
- Sponsor's protocol ID
- PHCL49
- Status last verified
- Dec 2016
- First submitted
- 20 Sep 2016
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ahmed Casper E, Mohmed El Wakeel L, Ayman Saleh M, Hamed El-Hamamsy M. The impact of a comprehensive pharmaceutical care intervention in addition to cardiac rehabilitation program on outcomes of post-acute coronary syndrome patients: A pilot study. Patient Educ Couns. 2022 Oct;105(10):3164-3168. doi: 10.1016/j.pec.2022.06.004. Epub 2022 Jun 10.
PubMed 35701314
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit
- ClinicalTrials.gov ID
- NCT02922140
- Acronym / sponsor ID
- PHCL49
- Conditions
- Acute Coronary Syndrome
- Keywords
- pharmaceutical care service, clinical pharmacist, Cardiac rehabilitation unit, Acute coronary syndrome, patient education and counselling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 4 Oct 2016 (estimated)
- 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.
This study aims to investigate the role of clinical pharmacist in the development of a pharmaceutical care program for patients with Acute coronary syndrome tailored to their specific learning needs and their cultural context, and to verify the program's effects on physiological factors and recurrent symptoms or cardiac events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –will receive standard care by physician in attendance |
| intervention group | Active comparator | Behavioral: pharmaceutical care servicewill be supplied by clinical pharmaceutical care services provided by the clinical pharmacist plus standard care by physician in attendance. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are diagnosed with Acute coronary syndrome (ischemic heart disease) by their primary cardiologist, treated with medication, percutaneous coronary angioplasty, or coronary artery bypass graft.
- At 20-79 years of age.
- Has the ability to perform regular physical activity according to the patients' self-identification and the judgment of their primary cardiologist.
- Willing to participate in this study.
- Able to be reached by telephone postdischarge.
Key exclusion criteria (5 listed)
- Patients with cognitive impairment.
- If they need professional help to take their medication at home.
- With terminal illness.
- Inability to communicate.
- Severe arrhythmia.
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 serviceAlso: pharmaceutical care plan, Comprehensive health care services | Behavioural | intervention group |
Primary outcome
Change in the level of patient education about disease, drugs and lifestyle modification using coronary artery disease education questionnaire (CADE-Q)
Time frame: three months
at baseline and after three months
Change in the number of solved drug-related problems
Time frame: three months
assessment of drug-related problems at baseline and solving them during three months
Assessment of medications adherence: (Eight-item Morisky adherence questionnaire).
Time frame: three months
at baseline and after three months
6 secondary outcomes
Assessment of quality of life: (36-items self-care Health survey (SF-36)).
Time frame: three months
Assessment of smoker's dependence on cigarette smoking: (using the Fagerstrom Test for Nicotine Dependence).
Time frame: three months
Change in heart rate [HR] (Bpm).
Time frame: three months
Change in Lipid profile : total cholesterol (mg/dl), triglycerides(mg/dl), and low density lipoprotein cholesterol(mg/dl), high density lipoprotein (mg/dl)
Time frame: three months
Change in levels of fasting blood glucose (mg/dl)
Time frame: three months
Change in systolic and diastolic blood pressure [BP] (mmHg).
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2016.
- Derived from this study: PubMed 35701314Ahmed Casper E, Mohmed El Wakeel L, Ayman Saleh M, Hamed El-Hamamsy M. The impact of a comprehensive pharmaceutical care intervention in addition to cardiac rehabilitation program on outcomes of post-acute coronary syndrome patients: A pilot study. Patient Educ Couns. 2022 Oct;105(10):3164-3168. doi: 10.1016/j.pec.2022.06.004. Epub 2022 Jun 10.
- Individual participant dataSharing planned: Undecided
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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.
Eman A. Casper, bachelor principal investigator
Ain Shams University
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 service in people with Acute Coronary Syndrome, run by Ain Shams University at 1 site in Egypt.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Dec 2016. 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 Egypt. 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?
Results are not available in the source record.
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 level of patient education about disease, drugs and lifestyle modification using coronary artery disease education questionnaire (CADE-Q) (time frame: three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02922140, which also lists 1 linked publication.
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 13 Dec 2016.