Problems With Access to Health CareNCT02101502
Quality Assurance of Obstetrics and Gynecology Department
A study testing Questioner in people with Problems With Access to Health Care, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This work aimed to prepare the obstetrics and gynecology department for high education and health care accreditation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Problems With Access to Health Care
- What is being tested?
- Questioner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2010to Jun 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Female patients attending the obstetrics and gynecology department
- Medical and assistant medical staffs
- institutional employees
Who cannot join
- Female patients complaining from disorders not included in the obstetrics and gynecology department activities.
- Male patients.
Trial locations and contacts
1 site in 1 country.
About this study
This work aimed to prepare the obstetrics and gynecology department for high education and health care accreditation.
Read the detailed description
For Institutional Capacity and Educational Effectiveness we have used a special questioner for assessment (Met or Not Met Questioner). For Quality Assurance System in Health-care we used a special questioner which contain several items each of them may be A ,B or C. A= structured standards, and are scored as M= Met or N=Not Met or NA=Not Applicable ,The B \&C standards are implementation standards . these standards are scored either on the number of observations , documentation of deficiencies , or non compliance with the standards.
- Conditions
- Problems With Access to Health Care
- Being tested
- Questioner
- Keywords
- Healthcare,educational effectiveness, institutional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionerOther
Obstetrics and gynecology health problems questionnaire for patients Educational effectiveness special questionnaire for medical staffs Institutional capacity special questionnaire for institution employees
| Study group | Role | What they receive |
|---|---|---|
| Institutional Capacity | Active comparator | Questioner for institutional employee about Institutional Capacity Receives: Other: Questioner |
| Educational Effectiveness | Active comparator | Questioner for medical and assistant staffs about Educational Effectiveness Receives: Other: Questioner |
| Health-care | Active comparator | Questioner for medical, assistant staffs and patients about Quality Assurance System in Health-care Receives: Other: Questioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality Assurance
QA=Quality Assurance
- Institutional Capacity
- Educational Effectiveness
- Obstetrical and Gynecological disorders of health care
Measured: One year and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startFeb 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problems With Access to Health CareStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edessy Mahmoud, Al-Azhar University
- Investigators
- Mahmoud Edessy, MD, Principal investigator, Al-Azhar UniversityAbd El-Naser Mohammad, MD, Study chair, Al-Azhar UniversityManal Abd El-Aty, MD, Study chair, Al-Azhar UniversityMahmoud Badawi, MSc, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101502
- Sponsor's protocol ID
- 1781955
- Status last verified
- Jun 2014
- First submitted
- 29 Mar 2014
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Assurance of Obstetrics and Gynecology Department
- ClinicalTrials.gov ID
- NCT02101502
- Acronym / sponsor ID
- 1781955
- Conditions
- Problems With Access to Health Care
- Keywords
- Healthcare,educational effectiveness, institutional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Apr 2014 (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 work aimed to prepare the obstetrics and gynecology department for high education and health care accreditation.
Detailed description
For Institutional Capacity and Educational Effectiveness we have used a special questioner for assessment (Met or Not Met Questioner). For Quality Assurance System in Health-care we used a special questioner which contain several items each of them may be A ,B or C. A= structured standards, and are scored as M= Met or N=Not Met or NA=Not Applicable ,The B \&C standards are implementation standards . these standards are scored either on the number of observations , documentation of deficiencies , or non compliance with the standards.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Institutional Capacity | Active comparator | Other: QuestionerQuestioner for institutional employee about Institutional Capacity |
| Educational Effectiveness | Active comparator | Other: QuestionerQuestioner for medical and assistant staffs about Educational Effectiveness |
| Health-care | Active comparator | Other: QuestionerQuestioner for medical, assistant staffs and patients about Quality Assurance System in Health-care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients attending the obstetrics and gynecology department
- Medical and assistant medical staffs
- institutional employees
Key exclusion criteria (2 listed)
- Female patients complaining from disorders not included in the obstetrics and gynecology department activities.
- Male patients.
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 |
|---|---|---|
| QuestionerObstetrics and gynecology health problems questionnaire for patients Educational effectiveness special questionnaire for medical staffs Institutional capacity special questionnaire for institution employees | Other | Educational Effectiveness, Health-care, Institutional Capacity |
Primary outcome
Quality Assurance
Time frame: One year and 4 months
QA=Quality Assurance * Institutional Capacity * Educational Effectiveness * Obstetrical and Gynecological disorders of health care
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 10 Jun 2014.
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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.
Mahmoud Edessy, MD principal investigator
Al-Azhar University
Abd El-Naser Mohammad, MD study chair
Al-Azhar University
Manal Abd El-Aty, MD study chair
Al-Azhar 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 Questioner in people with Problems With Access to Health Care, run by Al-Azhar 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 3 inclusion and 2 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 10 Jun 2014. 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?
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?
Quality Assurance (time frame: One year and 4 months). 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 10 Jun 2014.