[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06358261":3,"trial-entities:NCT06358261":88,"trial-summary:NCT06358261":92},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":68,"locations":71,"central_contacts":81,"overall_officials":82,"references":86,"see_also_links":87},"NCT06358261","IRB00433279","Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool","Pilot Study of a Diabetes Prevention Patient Activation Clinical Decision Support Tool","ENROLLING_BY_INVITATION","2027-02-01","2026-06","2026-06-08","2024-07-01","Johns Hopkins University","OTHER",false,"The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes\u002Flifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.","Patient activation, which incorporates elements of self-efficacy and readiness to change, is particularly important in managing conditions like pre-diabetes, where the mainstay of treatment is behavioral lifestyle change and self-management. Unfortunately, Primary Care Physicians (PCPs) often do not have adequate training on how to promote patient activation. Traditionally, patient decision aids are used in shared decision-making to help elicit patient preferences and guide treatment options. However, the guides primarily focus on reviewing treatment options rather than increasing patient activation, which is key to successful and efficient behavioral counseling. The Patient Activation Measure (PAM) is a widely used and validated patient-reported outcome measure for assessing patient activation. Studies have demonstrated that using PAM to tailor care to a patient's activation level decreased health service utilization while improving clinical outcomes like blood pressure and self-management behaviors.\n\nThe investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a pre-diabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to pre-diabetes\u002Flifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.",[19,20,21],"PreDiabetes","Lifestyle, Healthy","Activation, Patient",[],"INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},100,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Diabetes Prevention Patient Activation Clinical Decision Support Tool","Diabetes Prevention Patient Activation Clinical Decision Support Tool will be used by the doctor during the visit to discuss lifestyle management",[36],"Intervention Arm (DPACT)",[38],{"measure":39,"description":40,"timeFrame":41},"patient activation as assessed by the Patient Activation Measure Survey (PAM)","measured by Patient Activation Measure (PAM) survey, a 13-item scale with 4 Likert response,s and scores ranging from 0 to 100 (higher score means higher activation level)","baseline, 6 months",[43,46,48,51],{"measure":44,"description":45,"timeFrame":41},"number of participants referred to Diabetes Prevention Program","measured using electronic health record data",{"measure":47,"description":45,"timeFrame":41},"number of participants prescribed metformin",{"measure":49,"description":50,"timeFrame":41},"percent of participants who make diet changes","measured using survey developed by study team will assess what diet changes participants have made",{"measure":52,"description":53,"timeFrame":41},"change in amount and frequency of physical activity","measured using survey developed by study team will assess the change in amount and frequency of physical activity that participants have made","ALL","18 Years",null,true,{"inclusion":59,"exclusion":63,"raw_text":67},[60,61,62],"prediabetes","patient at Johns Hopkins General Internal Medicine clinic at Green Spring Station","MyChart account",[64,65,66],"history of diabetes","non-English speaker","severe intellectual disability or psychiatric comorbidities","Inclusion Criteria:\n\n* prediabetes\n* patient at Johns Hopkins General Internal Medicine clinic at Green Spring Station\n* MyChart account\n\nExclusion Criteria:\n\n* history of diabetes\n* non-English speaker\n* severe intellectual disability or psychiatric comorbidities",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Johns Hopkins Internal Medicine at Green Spring Station","Lutherville","Maryland","21093","United States",{"lat":79,"lon":80},39.42122,-76.62608,[],[83],{"name":84,"affiliation":13,"role":85},"Eva Tseng, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":91},[90],"Prediabetes",[],{"nct_id":4,"found":15,"summary":56,"prompt_version":56}]