Diabetes MellitusTRIPLE-CARENCT06807333
Transforming Diabetes Care: Pharmacist-Led Education and Its Impact on Patient Knowledge, Self-Management, and Health Outcomes
A study testing Pharmacist led Education in people with Diabetes Mellitus, run by Shifa International Hospital at 1 site in Pakistan.
Trial summary
This interventional study is to evaluate the impact of pharmacist-led education on diabetic patients' knowledge, self-management, and overall health outcomes. Participants in this study will attend pharmacist-led educational sessions designed to improve their understanding of diabetes and self-care practices. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Pharmacist led Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- We will include all confirmed diabetic patients who visit the SIH endocrinology OPD Clinic during the study duration.
- Both male and female patients visiting the Endocrinology Unit of the hospital will be eligible.
- Patients with HbA1c levels greater than 8% will be included.
- Both follow-up and newly diagnosed patients will be considered.
- Patients who sign the informed consent form will be enrolled in the study.
Who cannot join
- We will exclude patients with gestational diabetes mellitus (GDM).
- Patients with central obesity will not be included in the study.
- Type 1 diabetes mellitus (DM) patients under the age of 20 will be excluded.
- Patients with inadequate medical history will be excluded from participation.
- Patients with HbA1c levels less than 8% will not be included.
- Patients who do not provide informed consent or express a lack of interest in the study will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This interventional study is to evaluate the impact of pharmacist-led education on diabetic patients' knowledge, self-management, and overall health outcomes. Participants in this study will attend pharmacist-led educational sessions designed to improve their understanding of diabetes and self-care practices. Researchers will assess changes in patients' knowledge, self-management behaviors, and clinical health markers before and after the intervention. The study will compare pre- and post-intervention results to determine the effectiveness of pharmacist-led education in transforming diabetes care.
Read the detailed description
The purpose of this study is to investigate whether pharmacist-led education can enhance the knowledge, self-management behaviors, and health outcomes of diabetic patients. Effective diabetes management requires a comprehensive understanding of the disease, adherence to lifestyle modifications, and consistent monitoring of health indicators. Poor knowledge and suboptimal self-care can lead to inadequate glycemic control, complications, and reduced quality of life. This study will evaluate the impact of pharmacist-led educational interventions on patients' motivation, diabetes-related knowledge, and self-care behaviors, as well as their effects on clinical outcomes, including improved HbA1c levels, reduced hypo- and hyperglycemic episodes, and enhanced patient satisfaction. By addressing these critical aspects, the study aims to highlight the transformative role of pharmacist-led education in advancing diabetes care and fostering sustainable, patient-centered healthcare practices.
- Conditions
- Diabetes Mellitus
- Being tested
- Pharmacist led Education
- Keywords
- Pharmacist, Patient Knowledge, Self-Management, Health Outcome, HbA1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist led EducationBehavioural
Pharmacist-led education for diabetic patients focuses on enhancing their understanding of the disease, improving self-management skills, and promoting better health outcomes. The education covers key aspects of diabetes, such as the importance of blood sugar control, the role of diet and exercise, and how to monitor blood glucose levels. Patients are also taught effective self-management strategies, including how to make healthy food choices, incorporate physical activity into daily routines, and manage potential complications. By providing tailored education, pharmacists aim to empower patients to take an active role in their care, which can lead to improved disease management, better glycemic control, and reduced risk of complications.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | Lifestyle Modifications: Education on healthy meal choices and physical activity to support diabetes management. Disease Education: In-depth information on diabetes, blood sugar control, and the prevention of complications. Self-Management Tools: Provision of blood glucose monitoring charts and practical strategies for daily diabetes care. Counseling: Personalized counseling to address emotional aspects, stress management, and confidence in managing diabetes. Receives: Behavioral: Pharmacist led Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Knowledge Score(DKQ-24)
Patient's diabetes knowledge will be assessed using the Diabetes Knowledge Questionnaire (DKQ). The DKQ is a tool used to evaluate a patient's understanding of diabetes, including aspects such as blood sugar control, diet, exercise, and medication management. It consists of close-ended questions, with scores ranging from 0 to 100, where a higher score indicates a better level of knowledge regarding diabetes management.
Measured: 3 months
Diabetes Management Self-Efficacy Score (DMSQ-16)
Patient's diabetes self-management will be assessed using the Diabetes Self-Management Questionnaire (DMSQ). The DMSQ is a tool used to evaluate a patient's ability to manage their diabetes through self-care practices, including diet, physical activity, blood sugar monitoring, and medication adherence. It consists of close-ended questions, with scores ranging from 0 to 100, where a higher score reflects better self-management behaviors in managing diabetes.
Measured: 3 months
HbA1C Levels (%)
Patient's health outcomes will be assessed using HbA1c levels. HbA1c (glycated hemoglobin) is a blood test used to measure a patient's average blood sugar level over the past 3 months. It is a key indicator of diabetes management and glycemic control. The HbA1c level is reported as a percentage, with lower percentages indicating better control of blood sugar. A target HbA1c level of less than 7% is typically recommended for most diabetic patients. The score can range from high percentages (indicating poor control) to lower percentages (indicating better glycemic control).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SARA YAHYA, Shifa International Hospital
- Investigators
- Iqra Farooq, Mphil, Study director, Shifa International HospitalSara Ghulam Yahya, Ms., Principal investigator, Shifa International HospitalFaiza Abbas, Pharm-D, Study chair, Shifa International HospitalMatti Ullah, PhD, Study chair, Hamdard University Islamabad CampusSalwa Ahsan, Study chair, Shifa International HospitalOsama Ishtiaq, Endocrinologist, Study chair, Shifa International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807333
- Sponsor's protocol ID
- 318-24
- Acronym
- TRIPLE-CARE
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Diabetes Care: Pharmacist-Led Education and Its Impact on Patient Knowledge, Self-Management, and Health Outcomes
- ClinicalTrials.gov ID
- NCT06807333
- Acronym / sponsor ID
- TRIPLE-CARE / 318-24
- Conditions
- Diabetes Mellitus
- Keywords
- Pharmacist, Patient Knowledge, Self-Management, Health Outcome, HbA1c
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Shifa International HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 4 Feb 2025 (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.
This interventional study is to evaluate the impact of pharmacist-led education on diabetic patients' knowledge, self-management, and overall health outcomes. Participants in this study will attend pharmacist-led educational sessions designed to improve their understanding of diabetes and self-care practices. Researchers will assess changes in patients' knowledge, self-management behaviors, and clinical health markers before and after the intervention. The study will compare pre- and post-intervention results to determine the effectiveness of pharmacist-led education in transforming diabetes care.
Detailed description
The purpose of this study is to investigate whether pharmacist-led education can enhance the knowledge, self-management behaviors, and health outcomes of diabetic patients. Effective diabetes management requires a comprehensive understanding of the disease, adherence to lifestyle modifications, and consistent monitoring of health indicators. Poor knowledge and suboptimal self-care can lead to inadequate glycemic control, complications, and reduced quality of life. This study will evaluate the impact of pharmacist-led educational interventions on patients' motivation, diabetes-related knowledge, and self-care behaviors, as well as their effects on clinical outcomes, including improved HbA1c levels, reduced hypo- and hyperglycemic episodes, and enhanced patient satisfaction. By addressing these critical aspects, the study aims to highlight the transformative role of pharmacist-led education in advancing diabetes care and fostering sustainable, patient-centered healthcare practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Behavioral: Pharmacist led EducationLifestyle Modifications: Education on healthy meal choices and physical activity to support diabetes management. Disease Education: In-depth information on diabetes, blood sugar control, and the prevention of complications. Self-Management Tools: Provision of blood glucose monitoring charts and practical strategies for daily diabetes care. Counseling: Personalized counseling to address emotional aspects, stress management, and confidence in managing diabetes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- We will include all confirmed diabetic patients who visit the SIH endocrinology OPD Clinic during the study duration.
Key exclusion criteria (6 listed)
- We will exclude patients with gestational diabetes mellitus (GDM).
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 |
|---|---|---|
| Pharmacist led EducationPharmacist-led education for diabetic patients focuses on enhancing their understanding of the disease, improving self-management skills, and promoting better health outcomes. The education covers key aspects of diabetes, such as the importance of blood sugar control, the role of diet and exercise, and how to monitor blood glucose levels. Patients are also taught effective self-management strategies, including how to make healthy food choices, incorporate physical activity into daily routines, and manage potential complications. By providing tailored education, pharmacists aim to empower patients to take an active role in their care, which can lead to improved disease management, better glycemic control, and reduced risk of complications. | Behavioural | Interventional Group |
Primary outcome
Diabetes Knowledge Score(DKQ-24)
Time frame: 3 months
Patient's diabetes knowledge will be assessed using the Diabetes Knowledge Questionnaire (DKQ). The DKQ is a tool used to evaluate a patient's understanding of diabetes, including aspects such as blood sugar control, diet, exercise, and medication management. It consists of close-ended questions, with scores ranging from 0 to 100, where a higher score indicates a better level of knowledge regarding diabetes management.
Diabetes Management Self-Efficacy Score (DMSQ-16)
Time frame: 3 months
Patient's diabetes self-management will be assessed using the Diabetes Self-Management Questionnaire (DMSQ). The DMSQ is a tool used to evaluate a patient's ability to manage their diabetes through self-care practices, including diet, physical activity, blood sugar monitoring, and medication adherence. It consists of close-ended questions, with scores ranging from 0 to 100, where a higher score reflects better self-management behaviors in managing diabetes.
HbA1C Levels (%)
Time frame: 3 months
Patient's health outcomes will be assessed using HbA1c levels. HbA1c (glycated hemoglobin) is a blood test used to measure a patient's average blood sugar level over the past 3 months. It is a key indicator of diabetes management and glycemic control. The HbA1c level is reported as a percentage, with lower percentages indicating better control of blood sugar. A target HbA1c level of less than 7% is typically recommended for most diabetic patients. The score can range from high percentages (indicating poor control) to lower percentages (indicating better glycemic control).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- 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.
Iqra Farooq, Mphil study director
Shifa International Hospital
Sara Ghulam Yahya, Ms. principal investigator
Shifa International Hospital
Faiza Abbas, Pharm-D study chair
Shifa International Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist led Education in people with Diabetes Mellitus, run by Shifa International Hospital at 1 site in Pakistan.
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 6 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: opening soon, as of the sponsor's last update on 4 Feb 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iqra Farooq, Mphil (03335644661, iqra0989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Knowledge Score(DKQ-24) (time frame: 3 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?
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 4 Feb 2025.