INTRODUCTION:

Today's pharmacists are aware that the practice of pharmacy has expanded throughout time to encompass not just the dispensing and mixing of medications to patients, but also the provision of pharmaceutical care and interactions with patients and other healthcare providers. Improving patients' quality of life and giving them high-quality care is the primary function of patient counselling. Drug-related issues such negative effects, side effects, interactions with other medications, and mistakes made when taking medicine and other non-essential drug caused lower quality of life and impede access to high-quality healthcare.^1-4 In addition to reducing drug-related morbidity and its subsequent costs to the individual and Society. In addition to improving outcomes and increasing patient satisfaction with care, patient counselling has many other benefits for patients.^5-8

Patient education is one of the key management strategies for treating or halting the progression of many chronic diseases. Patient information brochures are the most useful tools for people with chronic illnesses like diabetes, hypertension (HTN), asthma, chronic obstructive pulmonary disease, and rheumatoid arthritis. Lack of knowledge has been mostly blamed for the patients' improper medicine. In order to comply with the medicine, patients must accurately comply with their treatment.⁹ The majority of patients in rural India lack health literacy and are illiterate, which can lead to drug misuse, improper use, drug-related issues, or discontinuation of ongoing therapy. Patient counselling must be used as a strategy for sensible drug use to address this problem.¹⁰As diabetes mellitus is a long-term condition that requires patients to effectively manage their lifestyle in order to achieve good health and function. Individuals with diabetes need to possess sufficient knowledge and a positive mindset towards self-care tasks like managing their diet, engaging in physical activity, taking medication, caring for their feet, and attending follow-up appointments. To live independently, individuals with diabetes should be in control of their own condition.^11-12-13

Depending on the patient's features and risk factors, such as age, sex, prior medical history, social history, and others, these diseases are typically handled with multiple pharmacological therapy or dual therapy.¹⁴ Additionally, because these illnesses impact various organ systems, patients are required prescriptions for two or more medications.^15-16 According to research conducted worldwide, patients who are receiving various medicinal therapies are more likely to have medication errors, unwanted side effects, adverse reactions, or higher medical costs.¹⁴ Patients with type II diabetes and hypertension may not take their medications as prescribed due to a variety of reasons, including the fact that their conditions are asymptomatic, the length of their therapy, side effects, and complex drug regimens. Noncompliance can also be greatly influenced by a lack of patient education and knowledge about managing their condition.¹⁷

Pharmaceutical care, or the provision of medication-related care to enhance the patient's quality of life, is absolutely necessary to close this gap.¹⁸ Due to their pharmacotherapeutic training, pharmacists play a crucial part in the prevention, detection, and repair of drug-related issues. According to Chemello et al. and Cipolle et al. the process entails retrieving patient and medication data, recording the objectives, assessing the therapeutic plan, recognising drug-related adverse events or any drug-related problem, responding to the problems, designing a monitoring plan, proposing the intervention to the doctor or patient, executing the intervention, and putting the monitoring plan into place. This will continuously improve the patient's quality of life.^19-20

Because clinical pharmacists can educate patients on medications, disease states, and therapeutic lifestyle changes like diet, exercise, and self-monitoring of blood pressure and blood glucose, their pharmaceutical care can therefore have a positive impact on patient care.²¹ Additionally, patients with single diseases rather than those who have co-morbid conditions are included in the majority of studies. Patients who have co-morbidities are more likely to be taking multiple medications and require further instruction and counselling.¹⁰ Therefore, the objective of this study was to evaluate the effectiveness of clinical chemists' counselling and teaching programmes for patients with comorbid hypertension and diabetes mellitus type-II.

MATERIALS AND METHODS:

Materials:

· Informed consent form

· Patient information sheet.

· Quality of life questionnaire.

· Patient counselling documentation form

· Patient information leaflet.

Study design and location:

This prospective cross-sectional study was carried out from January 2023 to April 2023 at the Apollo Hospital, a tertiary care facility in Bhat, Gandhinagar, Gujarat, India. The study protocol was examined and approved by Apollo Hospital's Institutional Review Board. The International Conference on Harmonization's Good Clinical Practice Guidelines and the ethical precepts derived from the Declaration of Helsinki were followed in the conduct of the study. Prior to enrollment, each research subject provided signed informed consent.

Study population:

The study comprised patients with hypertension and diabetes mellitus type – II having duration of two years, who were older than 18 years old, of either sex, and both inpatients and outpatients and willing to participate in the study. The study excluded participants who had seriously ill, severely disabled and who cannot be interviewed including pediatric patients and who denies for follow up. This study did not use a formal sample size calculation. According to the inclusion and exclusion criteria, total 300 patients were enrolled in the study after approval from ethics committee. Informed consent forms were signed by the patients and randomly equally divided into Control and case groups (150 patients each group).

Data collection procedure:

Case group patients were counselled by clinical pharmacist regarding indication, frequency, about their prescribed medication. Further knowledge about lifestyle modifications was given. SF12 questionnaire and medication reconciliation was checked and written in case report form. Where control group patients were not counselled regarding their medications or lifestyle modification by pharmacist. They followed the instructions that were given by the physicians when prescribed them medications. After 2 months were again follow up all patients and taken same data from patients. The study participants' sociodemographic information, clinical profile, and questionnaire disease features were recorded using a specifically created case report form.

Data analysis:

Data analysis was done using the SPSS. Student t-test was applied to assess the change in parameters between case and control groups.

RESULT:

After the scrutiny, using the inclusion and exclusion criteria 300 patients were enrolled into the study and were equally randomized into Case and Control groups. Among the total patients 62% were males and 38% were females. In the study the number of patients between the age groups of 60-69, 50-59 and 70-79 years were found to be more (39%, 25% and 19%, respectively), whereas patients between the age groups of 40-49, 30-39, 80-89, 20-29 years were found to be less (9%, 4%, 3% and 0.3 %, respectively). The educational status of patients was assessed and showed that 140(46.67%) undergraduate, 135(45 %) graduate, and 25(8.33%) post graduate. Out of 300 enroll patients 137(45.67%) have only hypertension, 29(9.67%) have only diabetes mellitus type-II and 134(44.67%) have both hypertension and diabetes mellitus type- II disease. Table 1 displays the distribution of patients based on sociodemographic variables.

Table 2 shows assessment of changes in blood pressure and blood sugar level in case and control group before and after counselling. Statistical data showed that both group having significant difference, but when observed about decrease in systolic and diastolic BP, random blood glucose levels, case group patients have more difference as compare to control group.

Table 3 data showed that assessment of Physical and mental component in patients. It showed that both group showed significant effect but as seen difference in before and after counselling case group have higher difference as compared to the control group patients.

Table 1 Demographic Details of study population.

	No. of Participants (%)
	Case group n = 150 (%)	Control group n = 150 (%)	Total n = 300 (%)
Gender
Male	94 (62.67)	92 (61.33)	186 (62)
Female	56 (37.33)	58 (38.67)	114 (38)
Age (Years)
20-29	1 (0.67)	0 (0)	1 (0.33)
30-39	7 (4.67)	6 (4)	13 (4.33)
40-49	15 (10)	12 (8)	27 (9)
50-59	44 (29.330	32 (21.33)	76 (25.33)
60-69	51 (34)	66 (440	117 (39)
70-79	29 (19.330	29 (19.33)	58 (19.33)
80-89	3 (2)	5 (3.33)	8 (2.67)
Education
Undergraduate	63 (42)	77 (51.33)	140 (46.67)
Graduate	73 (48.67)	62 (41.33)	135 (45.00)
Postgraduate	14 (9.33)	11 (7.33)	25 (8.33)
Disease
Hypertension (HT)	71 (47.33)	66 (44)	137 (45.67)
Diabetes mellitus type- II (DM-II)	17 (11.33)	12 (8)	29 (9.67)
HT + DM-II	62 (41.33)	72 (48)	134 (44.67)

Table 2: Assessment in change in BP and Random Blood sugar

	Case group		Control group
	Before counselling	After counselling	Before counselling	After counseling
Systolic BP	204.44±1.24	172.64± 1.67	194.74± 1.56	185.89± 1.98
Diastolic BP	79.31± 0.89	77.25± 0.55	78.27± 0.98	80.18± 1.25
Random Blood Sugar	204.45±5.07	172.64± 5.55	194.74± 6.65	184.11± 6.05

Table 3: Assessment of Physical and Mental component in Patients

	Case group		Control group
	Before counselling	After counselling	Before counselling	After counseling
Physical component	2.049± 0.23	2.95± 0.78	2.09± 0.13	2.12± 0.34
Mental component	3.14± 0.34	3.85± 0.89	3.08± 0.32	3.12± 0.67

DISCUSSION:

Our study evaluated the impact of clinical pharmacist counselling in terms of diabetic mellitus type-II and hypertension patient understanding of their disease, drug therapy and Lifestyle changes i.e. disease management (Systolic and diastolic pressure and random blood sugar) and quality of life.²²

62% males in the study showed that male have higher risk of HT and DM-II as compare to females. Many other research studies also reported that male has higher prevalence as compare to female. Our study data also reveals that 50-79 age groups have higher chance for hypertension and DM-II. This was similar to another study conducted in Bangalore where most of the patients were in the similar age group.⁹

Study performed by KV Ramanath and KR Venkappa, showed that average score for medication adherence significantly increased in older patients. The overall comparison of quality of life (QoL) scores revealed a significant improvement from the baseline to the last follow-up. The study demonstrated that clinical pharmacist involvement in rural hypertension therapy has a favorable effect on raising awareness of the condition, medications and their use, and their influence on quality of life. Study data reveled that, pharmaceutical interventions increased the quality of life of patients, knowledge, and decreased medication adherence, blood pressure and blood glucose levels. The findings of the current study confirm that pharmaceutical interventions, especially those for co-morbid disorders, have a good impact on patients' health.²³

A Study conducted in municipal hospital in Ghana showed reduction in the mean of glucose and blood pressure in diabetic and hypertensive patients. Similarly, we found, that the patients, who received counselling by pharmacist, observed a decrease in systolic and diastolic blood pressure as well as a decrease in mean glucose levels. They had more knowledge about their illness and better understanding of their lifestyle. Poor glycaemic management is linked to a number of issues that can cause impairments and even death. Patients' fasting plasma glucose levels benefit from the pharmacist participation in counselling and other forms of supportive treatment. After a month, the median blood glucose levels also decreased in both the case and control groups.²⁴

A large number of the patients were illiterate, so it was difficult for them to recall the name of the prescription. However, counselling helped them remember by providing the covers, colors, and strips for the medications, which helped them remember to take their medication as directed. This study provided compelling evidence for the need of patient education in boosting medication adherence for the treatment of sickness. The most common reasons for non-adherence among the patients who were enrolling were forgetfulness and financial difficulties. After counselling patient’s physical and mental component also increased, also showed significant difference in both groups. When compared to differences, case groups showed higher difference compare to control group which indicate the pharmacist interventions increase the quality of life and medication adherence.

The effectiveness of pharmacist led intervention program was clearly evident from the outcomes, which in turn also changed the perceptions and practices. Hypertension and diabetes mellitus type-II related education to patients plays an important role in controlling blood pressure, random blood glucose and improving medication adherence. Additionally, pharmacist intervention was recognized and appreciated by patients and healthcare providers in the current study. In addition to this patient also suggested to conducted education program at various community level to improve disease related outcomes.^25-27

The study's findings suggest that a significant portion of the population lacks awareness of DM. Earlier evidence had demonstrated poor awareness levels among those with diabetes and potential disease outcomes. However, the study reveals that individuals who regularly consult health care providers for diverse health concerns have greater awareness of the disease and its risk factors. This highlights the crucial role of healthcare providers, particularly community health workers and patient-focused practitioners, in raising awareness of diabetes mellitus among their patients and the wider community.²⁸

Limited data on long term benefits of the counselling provided to the patients due to the short span of the study. Many potential patients were reluctant to participate due to continuous follow up required in the study.

The positive outcomes of study will be helpful in involving pharmacist along with physician care for commonly occurring chronic illnesses. The study can further be expanded in future regarding its effect on vulnerable group like pregnant women and those with end stage liver disease and end stage renal disease. Provision of proper counselling to the patients with chronic disease will be helpful in better management of their existing condition.

CONCLUSION:

The study highlighted that education and patient counselling-based intervention improved blood pressure and medication adherence in hypertensive and diabetic patients. The intervention was helpful in enhancing knowledge and creating awareness regarding disease and medication. Similarly, our study made an overall positive impact on patients regarding pharmacist. Furthermore, this study report also addresses the pharmacist plays an important role in effective participation in management of hypertension and diabetes mellitus type - II as an essential part of traditional physician-based care which in addition will help in improving traditional framework of Indian healthcare system.

DECLARATION OF PATIENT CONSENT:

The authors attest that they have all necessary patient permission paperwork in their possession. The patient(s) has/have consented in the form for the publication of his/her photos and other clinical data in the journal. The patients are aware that although every attempt will be made to hide their identity and that their names and initials will not be published, anonymity cannot be ensured.

CONFLICTS OF INTEREST:

There are no conflicts of interest.

ACKNOWLEDGEMENT:

We author very thankful to Apollo Hospital and its Ethics Committee for approval of protocol and allow for the collection of the data for the study.

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Received on 09.06.2024 Revised on 24.10.2024

Accepted on 27.01.2025 Published on 02.08.2025

Available online from August 08, 2025

Research J. Pharmacy and Technology. 2025;18(8):3487-3491.

DOI: 10.52711/0974-360X.2025.00502

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.