[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578171":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":34,"studyPopulation":23,"armGroups":35,"interventions":48,"overallOfficials":23,"centralContacts":58,"locations":66,"responsibleParty":88,"collaborators":23,"id":92,"slug":23,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":23,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":117,"whyStopped":23,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Hamdard University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Medication adherence score","Adherence will be assessed using (Medication Adherence Reporting Scale) MARS-10.\n\nThis 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 \\\u003C6 is poor adherence, and \\>8 is high adherence.","3 months",{"measure":14,"description":15,"timeFrame":12},"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",[17,20],{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"HbA1c %","HbA1c levels (%) will be assessed before the intervention is provided and after 3 months.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":29,"maskingDescription":30,"whoMasked":31},"DOUBLE","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.",[32,33],"PARTICIPANT","OUTCOMES_ASSESSOR","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.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"Control Group","ACTIVE_COMPARATOR","Routine healthcare practices and protocols for diabetes management. Regular advice on medication, diet, and lifestyle modifications in accordance with established guidelines, Follows conventional approaches. 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.",[41],"Other: Basic Education",{"label":43,"type":44,"description":45,"interventionNames":46},"Cognitive Behavioral Interventional Group","EXPERIMENTAL","Specific Patient-centered strategies beyond routine care designed to address individualized needs. Customized interventions, including pharmacist-led educational sessions, personalized counseling, or advanced lifestyle modifications. Aims to enhance patient outcomes by providing tailored and innovative solutions for better diabetes management.\n\nChange in lifestyle \u002F link with any daily activity (Yoga and Meditation Specifically guide about food portions and how to balance each food group in daily routine along with recommended daily physical activity type and duration. Pill planner will also be provided to this group.\n\nMedication counselling, Insulin technique, Dose Adjustment, Titration, Insulin Correction.\n\nCognitive Behavioral Therapy will be provided.",[47],"Behavioral: Pharmacist-led Cognitive Behavioral therapy",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":23},"BEHAVIORAL","Pharmacist-led Cognitive Behavioral therapy","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.",[43],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":23},"Basic 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.",[37],[59,64],{"name":60,"role":61,"phone":62,"phoneExt":23,"email":63},"Matti Ullah, Ph.D Clinical Research","CONTACT","+92-331-5056501","mattiullah@hamdard.edu.pk",{"name":65,"role":61,"phone":23,"phoneExt":23,"email":23},"Iqra Farooq, M.Phil Pharmacy Practice",[67],{"facility":68,"status":23,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Shifa International Hospital","Islamabad","ICT","44000","Pakistan","PK",{"type":75,"coordinates":76},"Point",[77,78],73.04329,33.72148,{"lat":78,"lon":77},[81,85],{"name":82,"role":61,"phone":83,"phoneExt":23,"email":84},"Iqra Farooq, Mphil Pharmacy Practice","03335644661","iqra0989@gmail.com",{"name":86,"role":61,"phone":23,"phoneExt":23,"email":87},"Sara Ghulam Yahya, Ms Health Care Management","sara.ghulam@shifa.com.pk",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Matti Ullah","Assistant Professor","100578171",false,"NCT06807827","Pharmacist-Led Cognitive Behavioral Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life","Pharmacist-Led Educational Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life","COGNIPHARM-II","Inclusion Criteria:\n\nAll confirmed Type II diabetic patients who visit endocrinology OPD Clinic during study duration.\n\nPatients 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.\n\nExclusion Criteria:\n\nGDM diabetic patients Patients with Central Obesity Type I DM Patients Patients with inadequate medical history Patient having HbA1c \\\u003C8% Patient who are not interested in the study are excluded.","ALL","25 Years","70 Years",{"count":103,"type":104},385,"ESTIMATED","INTERVENTIONAL",[107],"NA","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.",[110],"Diabete Mellitus",[112,113,114,115,116],"Educational Intervention","Cognitive behavioral therapy","Pharmacist","Medication Adherence","Quality of life","NOT_YET_RECRUITING","2025-01-29",{"date":120,"type":121},"2025-02-04","ACTUAL",{"date":123,"type":104},"2025-02-20",{"date":125,"type":104},"2025-08-31",{"name":5,"class":6},1]