Impact of Clinical Pharmacist-Led Intervention on Management of Diabetic Hypertensive Patients in Eastern Nepal

Hypertension Clinical Trial

Official title:

Impact of Clinical Pharmacist Led Intervention on Management of Diabetic Hypertensive Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707481
• Other study ID #: 382/2022 PhD
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2023
• Est. completion date: October 30, 2025

Study information

• Verified date: August 2023
• Source: Chettinad Academy of Research and Education (Deemed to be University)
• Contact: Prasanna Dahal, PharmD
• Phone: +9779819316086
• Email: drprasannadahal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Diabetic-Hypertensives are at a higher risk of premature microvascular and macrovascular complications than diabetes alone. Proper lifestyle management, diet, disease monitoring, and medication adherence is essential in achieving desired therapeutic outcomes, preventing complications and improving those patients' Health-Related Quality of Life (HRQoL). Pharmacists are the most accessible healthcare professionals to the public and have a crucial role in optimizing treatment outcomes in patients with chronic diseases such as diabetes and hypertension. Experimental trials' demonstrating the potential roles of pharmaceutical services is scarce in the literature, particularly in developing countries of south Asia. Therefore, the investigators plan to conduct a prospective-interventional trial to determine the potential impacts of pharmacist-supervised educational intervention on the management of "Type II diabetic with comorbid hypertension" patients. Patient data will be collected using patient's clinical profile forms, General Medication adherence Scale (GMAS), Patients Satisfaction towards pharmaceutical services (PSPSQ), Health Related-KAP questionnaires. Data will be verified, stored, entered into databases, and analyzed according to the data management plan. The findings will be compared in terms of clinical and nonclinical outcome measures between the control and test groups to ascertain the conclusion.

Description:

Diabetics are twice as likely as non-diabetics to develop hypertension. Hypertension is a strong predictor of adverse cerebulo-vascular and cardiovascular events in people with diabetes, which increases risk of Premature micro-vascular and macro-vascular problems in patients encompassing both diseases. Therefore, strict glycemic and blood pressure control is essential to subdue complication and prevent dreadful cardiovascular events such as stroke, Ischemia and myocardial infarction. Participants with both chronic diseases may have lower HRQoL due to increased susceptibility towards cardiovascular comorbidities. Adherence to medication is equally crucial for treatment success. Pharmacist in collaboration with other healthcare members, could play a vital role in the care of patients and optimizing treatment outcomes in patients with chronic diseases .

Chronic disease management is of particular interest to clinical pharmacist since most intervention requires long-term prescription medication use. The international pharmaceutical federation (FIP) and world health organization (WHO) have implored pharmacists to support people with chronic disease through their expanded role that includes "pharmaceutical care." In Nepal, Clinical Pharmacy practice is still in early infancy, though few studies have shown encouraging impacts of pharmaceutical care services. Similarly, there is a significant gap in the literature in this region addressing the impact of pharmacist-supervised educational intervention on both clinical and nonclinical outcomes measures, primarily focusing on co-morbid Diabetes- Hypertensive patients. Therefore, these studies are intended to recap and fill that gap area and add new and valuable insight to the available literature.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 68 Years

Eligibility

Inclusion Criteria:

• Male and female patients aged 40 to 68 years.

• Clinically diagnosed with type II diabetes mellitus with hypertension as co-morbidity.

• Minimum one year of the medical history of diabetic and hypertension.

• Minimum 6 months on antidiabetic as well as antihypertensive medication therapy.

• Patients willing to participate in the study and those providing written informed consent for participation.

Exclusion Criteria:

• Patients with Type I diabetes mellitus, Diabetic insipidus, Gestational diabetes or other forms of diabetes.

• Presence of other chronic disease co-morbidity other than hypertension and diabetes complications.

• Mentally incompetent patients, Pregnant, critically ill patients (requiring hospital admission).

• Patients have tuberculosis, Corona virus, and other highly communicable diseases.

• Those patients not willing to performing routine follow-up visit.

Related Conditions & MeSH terms

• Hypertension
• Type 2 Diabetes

Intervention

Other:
• Clinical Pharmacist-Led Educational Intervention
Non Pharmacological management strategies include information related to life style modification, healthy dietary habits, physical activity and stress management techniques. In contrast, pharmacological educational intervention involves disease -related information ( diabetes/hypertension sign and symptoms, risk factor, complications, self-monitoring of blood pressure/glucose, symptoms and management of hypoglycemia/hypotension etc. ) and drug related information ( prescribed drug name, indication, contraindication, adverse effects etc.) as well as importance of adherence to prescribed medication and strategies to minimize DRPs issues. These teaching sessions will be carried out with the help of verbal communication, audio visual demonstration (including charts,pictorial etc) and information leaflets. Furthermore, a copy of educational package would be given to each participant for reference and guidance.

Locations

Country	Name	City	State
Nepal	Purbanchal University Hospital	Gothgaun,Sundar Haraicha Municipality, Morang	Province 1

Sponsors (2)

Lead Sponsor	Collaborator
Chettinad Academy of Research and Education (Deemed to be University)	Purbanchal University

Country where clinical trial is conducted

Nepal, 

References & Publications (4)

Naqvi AA, Hassali MA, Jahangir A, Nadir MN, Kachela B. Translation and validation of the English version of the general medication adherence scale (GMAS) in patients with chronic illnesses. J Drug Assess. 2019 Feb 6;8(1):36-42. doi: 10.1080/21556660.2019.1579729. eCollection 2019. — View Citation

Sakharkar P, Bounthavong M, Hirsch JD, Morello CM, Chen TC, Law AV. Development and validation of PSPSQ 2.0 measuring patient satisfaction with pharmacist services. Res Social Adm Pharm. 2015 Jul-Aug;11(4):487-98. doi: 10.1016/j.sapharm.2014.10.006. Epub 2014 Oct 22. — View Citation

Shrestha R, Sapkota B, Khatiwada AP, Shrestha S, Khanal S, Kc B, Paudyal V. Translation, Cultural Adaptation and Validation of General Medication Adherence Scale (GMAS) into the Nepalese Language. Patient Prefer Adherence. 2021 Aug 27;15:1873-1885. doi: 10.2147/PPA.S320866. eCollection 2021. — View Citation

Shrestha S, Sapkota B, Thapa S, K C B, Khanal S. Translation, cross-cultural adaptation and validation of Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0) into the Nepalese version in a community settings. PLoS One. 2020 Oct 9;15(10):e0240488. doi: 10.1371/journal.pone.0240488. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure	Assessed with measurement of Systolic and diastolic blood pressure in mmHg using sphygmomanometer	baseline, follow up at 3 months and 6 months respectively
Primary	Change in blood glycemic profile	Assessed with measurement of Fasting Blood Sugar (FBS) and Post Prandial Blood Sugar (PPBS) in mg/dl.	baseline, follow up at 3 months and 6 months respectively
Primary	change in glycosylated hemoglobin (HbA1C) level	assessed from patients glycosylated hemoglobin (HbA1C) level test, measured in percent (%)	baseline, follow up at 3 months and 6 months respectively
Primary	Impact of Intervention in Patients Medication Adherence	It will be measured using translated and validated Nepalese version of the 11-item Novel general medication adherence Scale (GMAS) questionnaire divided into three categories based on a four-level Likert scale. GMAS tools provide a wide range of components, including disease and medication burden, patient behavior both intentional and unintentional, and cost-related burden associated with non-adherence. Higher Scores better the outcomes, measured within categories and overall adherence level.	baseline, follow up at 3 months and 6 months respectively
Primary	Compare patients perceived Satisfaction of pharmaceutical care services	This will be assessed by using Nepali version of Patients Perceived satisfaction of Pharmacist care (PSPSQ. 2 ) questionnaire. This tool comprises 20 items questionnaire divided into three dimensions based on a four-point Likert scale. Dimensions include quality of care, pharmacist-patient relationships, and overall satisfaction. Higher scores represent better outcomes, measured within domains and overall satisfaction levels.	baseline, follow up at 3 months and 6 months respectively
Primary	Change in Health related Quality of Life	Translated Nepali version of Euro 5 D 5 L questionnaire measures will be used to measure patients' health-related quality of life (HRQoL). This questionnaire created by the European Quality of Life Group (EuroQol Group) measure HRQoL in five dimension Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five levels to describe the severity: no problem, slight problem, moderate problem, severe problem, and unable (very severe). The outcomes will be measured in the overall health utility index value. The index value ranges from -1 to 1 (0 indicates death, <0 indicates worse than death, and 1 indicates full health)	baseline, follow up at 3 months and 6 months respectively
Secondary	Change in routine clinical laboratory parameters of patients Lipid Profile test.	Data will be obtained from routine clinical laboratory test of patients blood Lipid Profile ( Total cholesterol, High density lipoprotein (HDL) Cholesterol, Low density lipoprotein (LDL) cholesterol, Very low density lipoprotein (VLDL) Cholesterol, and Triglycerides) measured in mg/dl.	baseline, follow up at 3 months and 6 months respectively
Secondary	Change in Patients health related Knowledge, Attitude and Practice	Patient knowledge, attitude and practice will be assessed using 25-item Disease related Health Knowledge, attitude and practice questionnaires developed by Investigators through literature review and content validated with a team of health care professionals. The higher the scores within domains better the outcomes.	baseline, follow up at 3 months and 6 months respectively

External Links

•   The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects, as compared to the EQ-5D-3L.