Diabetes Type IINCT02074540
The Influence of Health Beliefs and Uncertainty on Diabetes Type II Patient Compliance
An observational study of Diabetes Type II, run by Hillel Yaffe Medical Center.
Trial summary
To determine the predicting factors and indicators of compliance with insulin treatment in Diabetes Type II patients. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes Type II
- What is being tested?
- Questionnaire
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Dec 2014
- Phase
- Observational
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetes Type II patients who receive insulin and are hospitalized in the Hillel Yaffe Medical Center in a variety of departments. Patients are both Hebrew and Arabic speaking.
Who may be able to join
- With complete cognitive abilities
- Independent functioning
- Take insulin
Who cannot join
- Critically ill patients
- Psychiatric patients
Trial locations and contacts
No sites are listed yet.
About this study
To determine the predicting factors and indicators of compliance with insulin treatment in Diabetes Type II patients.
- Conditions
- Diabetes Type II
- Being tested
- Questionnaire
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire that is based on socio-demographic characteristics, Morisky's Four-Item Self-Reported Adherence Measure, Becker's Theory of Health Beliefs and Mishel's Theory of Uncertainty
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Type II Patients | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin adherence
Average number of positive responses on the questionnaire scale
Measured: Forty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type IIStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jalal Ashkar, MD, Study director, Hillel Yaffe Medical CenterRinat Majadly, RN, BA, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074540
- Sponsor's protocol ID
- HYMC-0005-14
- Status last verified
- Feb 2014
- First submitted
- 26 Feb 2014
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Health Beliefs and Uncertainty on Diabetes Type II Patient Compliance
- ClinicalTrials.gov ID
- NCT02074540
- Acronym / sponsor ID
- HYMC-0005-14
- Conditions
- Diabetes Type II
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 28 Feb 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.
To determine the predicting factors and indicators of compliance with insulin treatment in Diabetes Type II patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Type II Patients | – | Other: Questionnaire |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetes Type II patients who receive insulin and are hospitalized in the Hillel Yaffe Medical Center in a variety of departments. Patients are both Hebrew and Arabic speaking.
Key inclusion criteria (3 listed)
- With complete cognitive abilities
- Independent functioning
- Take insulin
Key exclusion criteria (2 listed)
- Critically ill patients
- Psychiatric 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 |
|---|---|---|
| QuestionnaireQuestionnaire that is based on socio-demographic characteristics, Morisky's Four-Item Self-Reported Adherence Measure, Becker's Theory of Health Beliefs and Mishel's Theory of Uncertainty | Other | Diabetes Type II Patients |
Primary outcome
Insulin adherence
Time frame: Forty minutes
Average number of positive responses on the questionnaire scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 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.
Jalal Ashkar, MD study director
Hillel Yaffe Medical Center
Rinat Majadly, RN, BA principal investigator
Hillel Yaffe Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Type II, run by Hillel Yaffe Medical Center.
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: status not confirmed, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Rinat Majadly, RN, BA (972-50-9366280, noona.412@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin adherence (time frame: Forty minutes). 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 28 Feb 2014.