[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550207":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":76,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":26,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"National Healthcare Group Polyclinics","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PACT Arm","EXPERIMENTAL","Participants in the intervention arm will undergo the PACT Program, which is a 3-month long health coaching program.",[13],"Behavioral: Patient Activation through Conversations (PACT) Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","PLACEBO_COMPARATOR","Patients in the Usual Care Arm will undergo routine follow-up for their Diabetes Mellitus. In NHGP, this involves Teamlet care, where patients are taken care of by a team comprising of Family Physicians, a Care Manager (a nurse trained in chronic disease management), and a Care Coordinator, and are seen typically every three to six months for monitoring of their diabetic control.",[19],"Behavioral: Usual Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Patient Activation through Conversations (PACT) Program","Participants in the intervention arm will undergo a 3-month long health coaching program where a care coach will review a participant's health parameters and current self-care behaviours, identify health motivators and set goals for improving their diabetes, as well as fortnightly support through text or phone call.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Routine Chronic Disease care",[15],[31],{"name":32,"affiliation":5,"role":33},"Sabrina Kay Wye Wong, MBBS","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":26,"email":39},"Jun Hwee Benjamin Lee, MBBS","CONTACT","+6563553000","benjamin_jh_lee@nhgp.com.sg",{"name":32,"role":37,"phone":38,"phoneExt":26,"email":41},"sabrina_kw_wong@nhgp.com.sg",[43,58,66],{"facility":44,"status":45,"city":46,"state":26,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"NHGP Geylang Polyclinic","NOT_YET_RECRUITING","Singapore","389707","SG",{"type":50,"coordinates":51},"Point",[52,53],103.85007,1.28967,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":38,"phoneExt":26,"email":39},"Jun Hwee Benjamin Lee",{"facility":59,"status":45,"city":46,"state":26,"zip":60,"country":46,"countryCode":48,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"NHGP Ang Mo Kio Polyclinic","569666",{"type":50,"coordinates":62},[52,53],{"lat":53,"lon":52},[65],{"name":57,"role":37,"phone":38,"phoneExt":26,"email":39},{"facility":67,"status":68,"city":46,"state":26,"zip":69,"country":46,"countryCode":48,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"NHGP Woodlands Polyclinic","RECRUITING","738579",{"type":50,"coordinates":71},[52,53],{"lat":53,"lon":52},[74],{"name":57,"role":37,"phone":75,"phoneExt":26,"email":39},"+65 63553000",{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[79],{"name":80,"class":6},"National Healthcare Group, Singapore","100550207","the-pact-patient-activation-through-conversations-study-100550207",false,"NCT06444074","The PACT (Patient Activation Through Conversations) Study","The PACT (Patient Activation Through Conversations) Study - A Cluster Randomised Trial of a Health Coach-led Patient Activation Program in Type 2 Diabetes.","PACT","Inclusion Criteria:\n\n* Individuals with a diagnosis of Type 2 Diabetes Mellitus who are enrolled in Teamlets in NHGP\n* Age between 21 to 64 years old\n* HbA1c level of more than 8% in the last 6 months\n\nExclusion Criteria:\n\n* History of acute coronary syndrome in the past 3 months\n* History of stroke or transient ischaemic attacks in the past 3 months\n* History of end stage organ failure (liver cirrhosis, cardiac failure, latest eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2 in the last 6 months)\n* Cancer requiring treatment in the past 5 years.\n* Active psychiatrist follow up\n* Social issues that are significant enough for follow-up or referral with a medical social worker within the last 12 months\n* Women who are pregnant or breastfeeding\n* Patients who are enrolled in other current diabetes-related interventional studies\n* Inability to provide written consent for the study protocol and able to commit to the study duration.","ALL","21 Years","64 Years",{"count":93,"type":94},432,"ESTIMATED","INTERVENTIONAL",[97],"NA","The PACT Study is a cluster randomised trial of a health coach-led patient activation program in type 2 diabetes. The goal of this clinical trial is to evaluate the effectiveness of a health coaching intervention (PACT program) led by Care Coaches (trained lay persons), in adult participants with sub-optimally controlled Diabetes Mellitus, as compared to participants undergoing routine care for diabetes (Usual Care).\n\nThe primary outcome of interest is change in Glycated Haemoglobin (HbA1c) levels over 3 months, 6 months and 12 months. Secondary outcomes include changes in blood pressure, low-density lipoprotein-cholesterol (LDL-C) levels, body mass index (BMI), self-reported diabetes self-care behaviours, self-efficacy, health-related quality of life, and diabetes-related distress, over 3, 6 and 12 months.\n\nParticipants in the Intervention arm will undergo the PACT Program, which is a 3-month long health coaching program led by a care coach. Participants review their motivators, health parameters, self-care behaviours, and set goals for improving their diabetes using a PACT report. Subsequently, they will receive fortnightly motivational and problem solving support via telephone or WhatsApp messaging over a 3-month duration, and will return to routine care after 3 months. Participants in the Usual Care arm will have routine care of their diabetes treatment.",[100,101],"Diabetes Mellitus","Diabetes Mellitus, Type 2",[100,103,104,105],"Health Coaching","Endocrinology","Lifestyle Intervention","2024-06-11",{"date":108,"type":109},"2024-06-13","ACTUAL",{"date":111,"type":109},"2024-04-22",{"date":113,"type":94},"2028-04-22",{"name":5,"class":6},3]