Diabete Mellitus
Conditions
Keywords
Educational Intervention, Cognitive behavioral therapy, Pharmacist, Medication Adherence, Quality of life
Brief summary
This interventional study will to assess the impact of pharmacist-led educational intervention along with cognitive behavioral intervention in diabetic patients. Participants of this study will be provided regular counselling or cognitive behavioral intervention and educational material as part of their routine pharmacy visit. Researchers will compare the two groups to see which of the two groups improve in term of medication adherence and quality of life.
Detailed description
The purpose of the study is to investigate whether incorporating pharmacist-led educational interventions along with Cognitive Behavioral Therapy (CBT) can result in better outcomes for diabetic patients. Effective diabetes management requires proper education and adherence to medication. Missed doses or irregular medication use can lead to poor glycemic control and increased complications. The study will examine if educational interventions along with Cognitive Behavioral Therapy (CBT) can have a favorable effect on various aspects of diabetes management coping techniques, Medication beliefs, reduction in hypo and hyperglycemic frequency, HbA1c and medication related problems (MRPs) medication adherence and overall quality of life of diabetic patients.
Interventions
Pharmacist-led Cognitive Behavioral therapy is patient centered approach that focus both physical and emotional aspect of health is provided. It is focused to identify negative and change negative thought pattern and behavior to improve mental and physical well being.Incorporation education about healthy meal choices, relaxation techniques, self management strategies,to improve education about potential adverse effect, how to recognize and on followup calls how to adjust medication doses along with this is provided.
OTHERBasic Education
Basic Education about lifestyle Modification(Provide guidance on how to maintain a healthy lifestyle, including balanced diet, exercise and regular sleep patterns). General Knowledge advancement. General knowledge about disease and medicine. Pill planner will be provided to keep them adherent to their medication. General Medication counselling.
Sponsors
Hamdard University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be entertained as part of their regular appointment for prescription filling without any information of which group they are assigned in. Moreover, following intervention, the outcomes will be assessed by the investigator who will be blinded about the participant group.
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
All confirmed Type II diabetic patients who visit endocrinology OPD Clinic during study duration. Patients having HbA1c \>8%. Follow up as well as new patients were included subjects willing to participate in the study with or without other severe co-morbidities were included in the study.
Exclusion criteria
GDM diabetic patients Patients with Central Obesity Type I DM Patients Patients with inadequate medical history Patient having HbA1c \<8% Patient who are not interested in the study are excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence score | 3 months | Adherence will be assessed using (Medication Adherence Reporting Scale) MARS-10. This scale describes three-dimension, Medication adherence behavior (1-4), attitude towards taking medication (5-8), negative side effects and attitudes to psychotropic medication (9-10). Each question has Yes and No response, a response consistent with adherence is coded as 1 and with non-adherence coded as 0. Higher the score higher will be the adherence. Adherence \<6 is poor adherence, and \>8 is high adherence. |
| Quality of life Score | 3 months | Patient's quality of life will be assessed using Revised Version of DQOL (RV-DQOL13 ; Audit of diabetes dependent quality of life) will be used to access the quality of life of the patient. Its scoring ranges from 1- 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Drug-Drug Interactions | 3 months | Drug interactions among oral anti glycemic and other drugs will be assessed using standard website (update-Lexicomp) It is used to access the reduction in no. of drug drug interaction after pharmacist intervention in both control and Cognitive Behavioral Intervention groups. |
| HbA1c % | 3 months | HbA1c levels (%) will be assessed before the intervention is provided and after 3 months. |
Countries
Pakistan
Contacts
Primary ContactMatti Ullah, Ph.D Clinical Research
Backup ContactIqra Farooq, M.Phil Pharmacy Practice
Outcome results
None listed