Evaluation of Improved Outcomes Among Ambulatory Diabetes and/or Hypertensive Patients - an Intervention Study (CPCLINT)

Study Overview
=================
Brief Summary
-----------------
The goal of this interventional study is to compare improved outcomes among diabetes and/or hypertensive patients sequel to educational intervention. The study aims to answer the following questions: What are the patients' levels of health literacy, medication adherence, disease knowledge, attitude to disease, physical activity? Does educational intervention by pharmacists improve health outcomes of patients with diabetes and/or hypertension? Are there associations between patient-related variables such as health literacy, medication adherence, disease knowledge, attitude to disease? Participants' anthropometric measurements and point-of-care testing for disease monitoring e.g., blood pressure, blood glucose would be carried out. Baseline assessment of participants would be done to evaluate their levels of health literacy, medication adherence, disease knowledge, attitude to disease, physical activity. Patients' baseline assessment would be carried out, after which they would receive educational materials and would be followed up by pharmacist. The baseline assessments would be repeated at three and six months after the intervention to measure the effectiveness of the intervention.

Detailed Description
-----------------
The anthropometric measurements would include weight, height, waist circumference, hip circumference, from which the body mass index and waist-hip ration would be calculated. The assessment of the disease knowledge and attitude would be done using validated semi-structured questionnaires earlier designed by the principal investigator and used among ambulatory patients with diabetes and/or hypertension accessing care in tertiary healthcare facilities. The validated International Physical Activity Questionnaire (IPAQ) would be utilized for participants' physical activity assessment.

Official Title
-----------------
Evaluation of Selected Improved Outcomes Among Patients With Diabetes and/or Hypertension in Designated Community Pharmacies in a Metropolitan City - An Intervention Study

Conditions
-----------------
Type 2 Diabetes Mellitus, Hypertension

Intervention / Treatment
-----------------
* Behavioral: Educational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum of 18 years of age Patients must be diagnosed with diabetes and/or hypertension Patients must be on at least one medication Patients who access one of the selected community pharmacies for prescription refill Exclusion Criteria: Non-consented patients Patients not based at the study site

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>All participants would undergo educational intervention by pharmacist. | Behavioral: Educational intervention<br>* Educational materials would be given to all the participants. They would also be followed up by pharmacist.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control | Participants' blood pressure in mmHg measured at baseline, 3- and 6-month postintervention would be compared to find out if there are changes. | 6 months | 
| Blood glucose control of participants | Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared. | 6 months | 
| Participants' level of disease knowledge and attitude | The knowledge and attitude scale in the semi-structured questionnaire would be evaluated at baseline, 3- and 6-month postintervention. | 6 months | 
| Participants' body mass index calculated by dividing weight in kilograms by the square of height in meters. | Participants weight in kilograms and height in meters would be measured at baseline, 3- and 6-month postintervention. Their body mass index would be compared to find out if there are changes. | 6 months | 
| Medication adherence of participants using a 4-item medication adherence scale | Participants' medication adherence would be evaluated at baseline, 3- and 6-month postintervention using Morisky, Green and Levine 4-item medication adherence scale. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Hypertension, Interventional study, Health literacy, Physical activity, Medication adherence, Pharmacist, Community pharmacy