Clinical trial NCT05707481: Impact of Clinical Pharmacist-Led Intervention on Management of Diabetic Hypertensive Patients in Eastern Nepal
Official title: Impact of Clinical Pharmacist Led Intervention on Management of Diabetic Hypertensive Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Hypertension
Lead sponsor: Chettinad Academy of Research and Education (Deemed to be University)
Sponsor class: OTHER
Collaborators: name: Purbanchal University
First posted: 2023-02-01
Enrollment: 92
Sex: ALL
Minimum age (years): 40
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in blood pressure
timeFrame: baseline, follow up at 3 months and 6 months respectively
measure: Change in blood glycemic profile
timeFrame: baseline, follow up at 3 months and 6 months respectively
measure: change in glycosylated hemoglobin (HbA1C) level
timeFrame: baseline, follow up at 3 months and 6 months respectively
measure: Impact of Intervention in Patients Medication Adherence
timeFrame: baseline, follow up at 3 months and 6 months respectively
measure: Compare patients perceived Satisfaction of pharmaceutical care services
timeFrame: baseline, follow up at 3 months and 6 months respectively
measure: Change in Health related Quality of Life
timeFrame: baseline, follow up at 3 months and 6 months respectively
Secondary outcomes:
measure: Change in routine clinical laboratory parameters of patients Lipid Profile test.
timeFrame: baseline, follow up at 3 months and 6 months respectively
measure: Change in Patients health related Knowledge, Attitude and Practice
timeFrame: baseline, follow up at 3 months and 6 months respectively
Other outcomes:
Locations:
city: Gothgaun,Sundar haraicha municipality, Morang
country: Nepal
facility: Purbanchal University Hospital
state: Koshi
Study officials:
affiliation: Chettinad Academy of Research and Education (Deemed to be University)
name: Prasanna Dahal, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.