Diabetes Mellitus, Type 1NCT06547970
Pharmacist Led Educational Intervention on QOL, Medication Adherence & Satisfaction on Patients With Type 1 DM
A study testing Educational intervension in people with Diabetes Mellitus, Type 1, run by University of Baghdad at 1 site in Iraq.
Trial summary
There was no previous study in Iraq to evaluate the efficacy of pharmacist-led educational intervention on patient glycemic control, quality of life and medication adherence among type 1 diabetic patients in Iraq. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Educational intervension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 1 Feb 2024to 1 Sep 2024
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - Patients age ≥ 16 years old who can speak and read the Arabic language.
- Had been diagnosed with T1DM for at least 6 months ago.
- Had uncontrolled hyperglycemia (glycosylated hemoglobin HbA1C ≥7% and/or fasting blood glucose >130 mg/dl)
- Patients on the same regimen the last 3 months.
- patients (or parents) acceptance to participate in the study.
Who cannot join
- 1-Patient who have hearing, speech or cognitive deficits that would impair understanding of the questions and receiving the education.
- 2- Patients with comorbid conditions that may interfere with the study such as asthma, thyroid disorders, adrenal gland disorders, celiac disease, or significant renal impairment.
- 3-Patients who are taking corticosteroids. 4- Patients who required changing their insulin regimen, increasing the dose >20% of the previous dose. (21) 5- Patients with conditions that affect red blood cell turnover (hemolytic and other anemias, G-6-PD deficiency, recent blood transfusion, use of drugs that stimulate erythropoiesis, end stage kidney disease and pregnancy.
- 6-Patients unwilling to participate.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Al-kindy Specialized center for endocrine diseases and diabetes
Baghdad, 12221
Mukdad Al Hilal, PhD, 7712763103 ext. 00964
About this study
Official title: The Impact of Pharmacist Led Education Program on Glycemic Control, Quality of Life and Medication Adherence Among Patients With Type 1 Diabetes Mellitus
There was no previous study in Iraq to evaluate the efficacy of pharmacist-led educational intervention on patient glycemic control, quality of life and medication adherence among type 1 diabetic patients in Iraq.
Improving diabetes patients' information's about their disease control, the role of insulin and the right technique to administer it, how to deal with hyper- and hypoglycemia, about their diet and exercise.
It is important to conduct a study to evaluate the pharmacist's role in education and improving patients' quality of life.
Read the detailed description
Aim of the Study:
The aim of the current study is to evaluate the impact of pharmacist-led educational intervention on glycemic control, quality of life and medication adherence among type 1 diabetic patients.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Educational intervension
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervensionOther
Also called follow up
an educational intervention about the disease, symptoms \& how to deal with these symptoms, foot care, life style like sport and nutritional advices
| Study group | Role | What they receive |
|---|---|---|
| Control (no education) | Placebo comparator | a group of DM patients we will record their HbA1C , FBG \& their QOL by filling the questionnaire (will be filled by the researcher herself then after 3 months we are going to record the same variables Receives: Other: Educational intervension |
| Patient education | Active comparator | a group of DM patients we will record their HbA1C , FBG \& their QOL, medication adherence , insulin taking technique form ( the questionnaire \& form will be filled by the researcher herself) then an educational session will last about 30 min. will be given to each patient face to face at the last the recearcherr and the patients will share their phone numbers for following up then after 3 months all the variables will be recorded again Receives: Other: Educational intervension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin A1c (%) (HbA1c)
Measurement of Glycated hemoglobin A1c (%) (HbA1c) at beginning of the intervention and the end of 3 months follow-up.
Measured: Baseline (beginning of the intervention) and the end of 3 months follow-up.
The Quality of Life Scale (QoL)
The score consists of four major domains including general health, social, psychological, and satisfaction issues. Ten items were selected to formulate the quality-of-life scale for Iraqi DM patients (QOLSID). The first four questions with question ten are used to directly assess satisfaction, question five is used to assess social issue while questions six and seven were used to assess emotion and stress finally question eight and nine are directly used to assess health issue. The score of each question range from 0 (poor) to 5 (optimum). Items 1,2,6 and 7 with reverse scoring. Total score = direct summation of all items scores. Total scores ≥ 32.5 points refer to good quality of life.
Measured: Baseline (beginning of the intervention) and the end of 3 months follow-up.
Secondary outcomes (2)
Anti-Diabetic Medication Adherence Scale (IADMAS)
The scale consists of eight items; three items are used to directly assess medication-taking behavior by giving five responses: (1) always (daily), (2) often, (3) sometimes, (4) rarely and (5) never. The remaining five items are used to measure the determinant of non-adherence by giving a dichotomous response of "Yes" or "No". The first item aims to identify the extent of unintentional missing of medication doses; all other questions were directed to identify the extent of intentional medication non-adherence. Two items (1 and 3) were used to identify the extent of non-adherence to the time of medication taking. Four items (2, 6, 7 and 8) were formulated to identify the extent of intentional non-adherence with the prescribed medication dose. Only one item (5) aims to identify the extent of intentional non-adherence through discontinuation of taking DM medication. Scoring of all items ranged from 0 to 1, 0 for non-adherent answer and 1 for total adherence.
Measured: Baseline (beginning of the intervention) and the end of 3 months follow-up.
Insulin self-administration assessment checking list
The assessment form was developed based on the latest expert recommendations for best practice in insulin injection technique. to assess pharmacists' counseling and educational role about the use of insulin. Areas of assessment include Preparations for injecting insulin contain six questions, Insulin injecting technique contain nine questions, Storage and stability of insulin contain 2 questions. the answers would be yes and no
Measured: Baseline (beginning of the intervention) and the end of 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Feb 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwah Salman Abdulrahman, University of Baghdad
- Investigators
- Ali Lateef Jasim, PhD, Study director, Baghdad University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547970
- Sponsor's protocol ID
- DM type 1
- Status last verified
- Aug 2024
- First submitted
- 24 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pharmacist Led Education Program on Glycemic Control, Quality of Life and Medication Adherence Among Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06547970
- Acronym / sponsor ID
- DM type 1
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 12 Aug 2024 (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.
There was no previous study in Iraq to evaluate the efficacy of pharmacist-led educational intervention on patient glycemic control, quality of life and medication adherence among type 1 diabetic patients in Iraq.
Improving diabetes patients' information's about their disease control, the role of insulin and the right technique to administer it, how to deal with hyper- and hypoglycemia, about their diet and exercise.
It is important to conduct a study to evaluate the pharmacist's role in education and improving patients' quality of life.
Detailed description
Aim of the Study:
The aim of the current study is to evaluate the impact of pharmacist-led educational intervention on glycemic control, quality of life and medication adherence among type 1 diabetic patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (no education) | Placebo comparator | Other: Educational intervensiona group of DM patients we will record their HbA1C , FBG \& their QOL by filling the questionnaire (will be filled by the researcher herself then after 3 months we are going to record the same variables |
| Patient education | Active comparator | Other: Educational intervensiona group of DM patients we will record their HbA1C , FBG \& their QOL, medication adherence , insulin taking technique form ( the questionnaire \& form will be filled by the researcher herself) then an educational session will last about 30 min. will be given to each patient face to face at the last the recearcherr and the patients will share their phone numbers for following up then after 3 months all the variables will be recorded again |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- - Patients age ≥ 16 years old who can speak and read the Arabic language.
- Had been diagnosed with T1DM for at least 6 months ago.
- Had uncontrolled hyperglycemia (glycosylated hemoglobin HbA1C ≥7% and/or fasting blood glucose >130 mg/dl)
- Patients on the same regimen the last 3 months.
- patients (or parents) acceptance to participate in the study.
Key exclusion criteria (4 listed)
- 1-Patient who have hearing, speech or cognitive deficits that would impair understanding of the questions and receiving the education.
- 2- Patients with comorbid conditions that may interfere with the study such as asthma, thyroid disorders, adrenal gland disorders, celiac disease, or significant renal impairment.
- 3-Patients who are taking corticosteroids. 4- Patients who required changing their insulin regimen, increasing the dose >20% of the previous dose. (21) 5- Patients with conditions that affect red blood cell turnover (hemolytic and other anemias, G-6-PD deficiency, recent blood transfusion, use of drugs that stimulate erythropoiesis, end stage kidney disease and pregnancy.
- 6-Patients unwilling to participate.
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 |
|---|---|---|
| Educational intervensionAlso: follow upan educational intervention about the disease, symptoms \& how to deal with these symptoms, foot care, life style like sport and nutritional advices | Other | Control (no education), Patient education |
Primary outcome
Glycated hemoglobin A1c (%) (HbA1c)
Time frame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
Measurement of Glycated hemoglobin A1c (%) (HbA1c) at beginning of the intervention and the end of 3 months follow-up.
The Quality of Life Scale (QoL)
Time frame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
The score consists of four major domains including general health, social, psychological, and satisfaction issues. Ten items were selected to formulate the quality-of-life scale for Iraqi DM patients (QOLSID). The first four questions with question ten are used to directly assess satisfaction, question five is used to assess social issue while questions six and seven were used to assess emotion and stress finally question eight and nine are directly used to assess health issue. The score of each question range from 0 (poor) to 5 (optimum). Items 1,2,6 and 7 with reverse scoring. Total score = direct summation of all items scores. Total scores ≥ 32.5 points refer to good quality of life.
2 secondary outcomes
Anti-Diabetic Medication Adherence Scale (IADMAS)
Time frame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
Insulin self-administration assessment checking list
Time frame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
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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.
Ali Lateef Jasim, PhD study director
Baghdad 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 Educational intervension in people with Diabetes Mellitus, Type 1, run by University of Baghdad 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 5 inclusion and 4 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 12 Aug 2024. 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. Some participants in this study may receive a placebo. 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 Marwa Al Mukhtar, MSc (7901735013 ext. 00964, marwa.abd2200m@copharm.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin A1c (%) (HbA1c) (time frame: Baseline (beginning of the intervention) and the end of 3 months follow-up.). The study lists 2 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 12 Aug 2024; AzTrials last refreshed its copy on 1 Nov 2026.