Impact of Pharmaceutical Care Interventions on Health Outcomes of Patients With Type 2 Diabetes Mellitus in Yobe State University Teaching Hospital

NCT07507305 | Completed

• 1 other identifier: YSUTH/MAC/EA/077/T/190
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: Many people with diabetes in Nigeria have trouble controlling their blood sugar. This can lead to serious health problems such as heart disease, kidney damage, eye problems, and nerve pain. Medicines alone are often not enough if patients do not take them correctly, understand how to use them, or make healthy lifestyle changes. This study looks at whether extra support from a pharmacist can help patients with type 2 diabetes mellitus get better health results. The study is being done at Yobe State University Teaching Hospital in Nigeria. What the study is about: The investigators want to find out if a special "pharmaceutical care" program run by a pharmacist can improve participants' blood sugar control and overall health compared to the usual care they receive in the hospital. What participants will do: Participants who agree to join the study will be divided into two groups by chance. One group will receive the normal diabetes care from doctors and nurses. The other group will receive normal care plus regular meetings with a trained pharmacist. In the pharmacist sessions, participants will get: Clear explanations about their diabetes medicines (why they are needed, how and when to take them, and possible side effects). Help to solve any problems with taking medicines correctly. Simple advice on healthy eating, physical activity, and checking blood sugar at home. Regular follow-up to answer questions and check progress. No new or experimental drugs are being tested. No injections, surgeries, or invasive procedures are involved. Patients continue with their usual diabetes medicines prescribed by their doctors. Why this matters: If the pharmacist support helps patients control their blood sugar better and feel healthier, it could be a simple and useful way to improve diabetes care in hospitals like ours. Better control can reduce the risk of serious complications and improve quality of life for patients and their families. The study will measure changes in blood sugar levels (HbA1c), blood pressure, how well patients take their medicines, and how they feel about their health. Investigators will compare the two groups after several months. This research does not involve any risk beyond the usual care patients already receive. Participation is voluntary, and patients can leave the study at any time without affecting their normal treatment.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; pharmaceutical care intervention; glycated hemoglobin

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin

  6 months interval

Study Arms (2)

Usual Care Group

PLACEBO COMPARATOR

This study arm received the usual care offered by the hospital, which include physician consultation, routine laboratory investigations and prescription refill

Behavioral: Usual Care

Pharmaceutical Care Group

ACTIVE COMPARATOR

In addition to services received by the usual care group, this arm received 1. Review and optimization of prescriptions to ensure safe and effective therapy 2. Identification and resolution of drug therapy problems 3. Clarification of medication usage and disease-related questions, offering tailored support based on patient-specific challenges 4. Education on prevention and management of diabetes-related complications 5. Hands-on training on the use of Self-Monitoring of Blood Glucose devices 6. Provision of monthly blood glucose logbooks 7. Interpretation of blood glucose values to enhance patient engagement and monitoring 8. Individual counselling sessions addressing psychosocial and behavioural concerns 9. Personalized dietary guidance tailored to each patient's needs 10. Distribution of diabetes infographic leaflets to reinforce learning and promote adherence

Behavioral: Pharmaceutical Care

Interventions

Pharmaceutical Care BEHAVIORAL

1. Review and optimization of prescriptions to ensure safe and effective therapy 2. Identification and resolution of drug therapy problems (DTPs) 3. Clarification of medication usage and disease-related questions, offering tailored support based on patient-specific challenges 4. Education on prevention and management of diabetes-related complications 5. Hands-on training on the use of Self-Monitoring of Blood Glucose (SMBG) devices 6. Provision of monthly blood glucose logbooks (Appendix VII) 7. Interpretation of blood glucose values to enhance patient engagement and monitoring 8. Individual counselling sessions addressing psychosocial and behavioural concerns 9. Personalized dietary guidance tailored to each patient's needs 10. Distribution of diabetes infographic leaflets to reinforce learning and promote adherence

Pharmaceutical Care Group

Usual Care BEHAVIORAL

Physician consultation, routine laboratory investigation, prescription refill

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients diagnosed with type 2 diabetes mellitus, confirmed by clinical documentation.
• \. Patients who have received oral antidiabetic and/ or insulin therapy within the 30 days prior to recruitment.
• \. Patients who have demonstrated consistent attendance at clinic visits for three consecutive months before recruitment.
• \. Patients who are proficient in either English or Hausa 5. Patients who provided written consent to participate in the study in accordance with ethical standards.
• \. Patients aged 18 years or older.

You may not qualify if:

• \. Critically ill patients 2. Pregnant women

Sponsors & Collaborators

• University of Maiduguri: lead

Study Sites (1)

Yobe State University Teaching Hospital

Maiduguri, Borno State, Nigeria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: February 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 31, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

NG (1)