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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-22

Study Completion Date

2024-07-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group (Usual Standard Care)

Control group patient will undergo routine care by their physician and nurses. However, the investigator will only provide basic counseling regarding drug prescribed during discharge to the patients. In another term "Usual care" will be provided to the patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group (Clinical Pharmacist-led educational Intervention)

In addition to routine care by physician and nurses, Patients in interventional group will receive two consecutive face to face interview and counseling of 20-40 minutes during the baseline period and the first follow-up period at 3-month by clinical pharmacist. Teaching and counseling session involves information on various non-pharmacological and pharmacological disease management strategies.

Group Type OTHER

Clinical Pharmacist-Led Educational Intervention

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No