Pharmacist-Led Cognitive Behavioral Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorHamdard University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pharmacist-led Cognitive Behavioral therapy

    Behavioral

    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.

  • Basic Education

    Other intervention

    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.

Treatment groups

385 Participants
are divided into 2 treatment groups
Group A: Control GroupActive comparator 1 intervention
Group B: Cognitive Behavioral Interventional GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Medication adherence score

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.

Time frame
3 months
2

Quality of life Score

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

Time frame
3 months

Secondary outcomes

1

Incidence of Drug-Drug Interactions

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.

Time frame
3 months
2

HbA1c %

HbA1c levels (%) will be assessed before the intervention is provided and after 3 months.

Time frame
3 months

Other outcomes

Sponsors and contacts

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