[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06397339":3,"trial-entities:NCT06397339":101,"trial-summary:NCT06397339":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":61,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":70,"locations":73,"central_contacts":95,"overall_officials":98,"references":99,"see_also_links":100},"NCT06397339","19630","Indian Transforming Alzheimer's Care Training (INTACT)","UNKNOWN","2026-04-30","2024-08","2024-08-19","2022-10-05","Washington State University","OTHER",true,"INTACT will utilize a group-randomized trial, to test the effectiveness of a culturally informed provider training and \"dementia friendly clinic\" intervention for detection and appropriate management of AI\u002FAN patients with ADRD and MCI in 28 urban and rural clinics serving AI\u002FANs.","The INTACT team will conduct a group-randomized trial (GRT) to test the effectiveness of the INTACT program, a culturally informed primary care provider training and clinic level workflow intervention for detection and appropriate management of AI\u002FAN patients with Mild Cognitive Impairment (MCI) and ADRD in 28 urban and rural clinics serving AI\u002FANs. The clinics are the primary unit of randomization. Within each participating clinic, PCPs who are routinely seeing AI\u002FAN patients ages 55 years and older will be recruited for data collection at baseline and 1-year follow-up. Each clinic will be randomized either to the immediate intervention or to a wait-list control arm. Data will be collected from PCP questionnaires, Electronic Health Records (EHR) data extraction and manual medical chart reviews. At the clinic level, we will rely on EHRs to document INTACT's effect on new ADRD diagnoses. At the PCP level, we will test whether INTACT increases knowledge and confidence in dementia assessment, ADRD care, and caregiver support. Patient-level data will be collected from the EHR and by manual chart review.\n\nOnce enrolled, clinics will complete a clinic profile interview and clinic and patient population information form, PCPs will be consented and complete a baseline survey. Next the clinics will be randomized into the immediate intervention or the wait-list control arms. Data collection will be conducted at baseline and 1-year follow-up. After completing the 1-year study period, clinics in the wait-list arm will have the opportunity to receive the INTACT intervention.",[18],"Alzheimer Disease",[20],"ADRD, MCI","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},28,"ESTIMATED",[29],{"type":13,"name":30,"description":31,"armGroupLabels":32},"INTACT Program","The INTACT Program has three components:\n\n1. provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,\n2. at the PCP level, provide quarterly webinars. Topics will address driving and dementia; communication tips for someone with dementia; eating and drinking in advanced dementia; and advanced care planning for dementia.\n3. At the clinic level, provide a workflow model for cognitive evaluation and setting a plan for the newly diagnosed patient. The INTACT intervention lasts 12 months and Continuing Medical Education credits will be available to PCPs who complete the INTACT training program",[33,34],"Intervention","Waitlist",[36,40,44,47,50,53,56,59],{"measure":37,"description":38,"timeFrame":39},"Clinic Level - new diagnoses of ADRD and MCI (Aim 2)","Primary outcome (as obtained directly from EHRs) will reflect the aggregate counts of new diagnoses (MCI, ADRD, other dementia) during the study period, based on the ICD-10 codes for these diagnoses.","Baseline and 12-month follow-up",{"measure":41,"description":42,"timeFrame":43},"PCP level - care confidence (Aim 1)","Within each clinic, each participating PCP will complete a baseline and a 12-month follow-up survey. The PCP level primary outcome is care confidence in providing dementia care to patients and their families. Care confience wil be measured using the General Practitioners Confidence and Attitude scale for Dementia (GPACS-D) whic uses a 5 point Likert scale from 1 (strongly agree) to 5 (strongly disagree). The GPACS-D scale has 3 subscales:\n\n1. Confidence in Clinical Abilities for which a lower score means a better outcome\n2. Attitude to Care for which a lower score means a better outcome\n3. Engagement for which a higher score means a better outcome","Baseline and a 12-month follow-up",{"measure":45,"description":46,"timeFrame":43},"Patient level - quality of care 1 (Aim 3)","Primary outcome (as obtained directly from EHRs) will reflect the number and type of ADRD diagnostic tests.",{"measure":48,"description":49,"timeFrame":43},"Patient level - quality of care 2 (Aim 3)","Primary outcome (as obtained directly from EHRs) will reflect the number of prescriptions of appropriate medications for cognitive and mood symptoms.",{"measure":51,"description":52,"timeFrame":43},"Patient level - quality of care 3 (Aim 3)","Primary outcome (as obtained directly from EHRs) will reflect the number of annual cognitive assessments.",{"measure":54,"description":55,"timeFrame":43},"Patient level - quality of care 4 (Aim 3)","Primary outcome (as obtained directly from EHRs) will reflect the number advance care directive.",{"measure":57,"description":58,"timeFrame":43},"Patient level - quality of care 5 (Aim 3)","Primary outcome (as obtained directly from EHRs) will reflect the number of annual evauations of functional status.",{"measure":57,"description":60,"timeFrame":43},"Primary outcome (as obtained directly from EHRs) will reflect the number of pharmacoligical treatment changes.",[],"ALL","18 Years",null,false,{"inclusion":67,"exclusion":68,"raw_text":69},[],[],"CLINIC Eligibility criteria\n\nTo be eligible to participate in INTACT a clinic must be:\n\n1. A primary care clinic\n2. Have at least 20 AI\u002FAN active patients 55 years or older\n3. Have an EHR system\n4. Not intending to change EHR systems in the next year\n5. Willing to conduct a total of 40 limited patient chart reviews to assess quality of care metrics for AI\u002FAN patients with MCI and ADRD, staff permitting\n\nPCP\n\nEligibility criteria:\n\nTo be eligible to participate in the baseline and follow-up surveys a primary care provider must be:\n\n1. have a title of MD, DO, Nurse Practitioner, or PA, and\n2. regularly provides care to AI\u002FANs aged 65 and older.\n\nPATIENTS\n\nWe will only collect patient EHR data from eligible patients who:\n\n1. Recorded as AI\u002FAN in the EHR system\n2. Active clinic patient with prevalent ADRD as of the first day of the time period each data extraction will cover\n3. Age 55 or older at the start of the surveillance interval\n4. At least one primary care clinic visit during the time period each data extraction will cover.\n\nThere are no exclusion criteria for the clinic, PCPs and patients.",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":12,"status":75,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":92},"RECRUITING","Seattle","Washington","98101","United States",[81,86,90],{"name":82,"role":83,"phone":84,"email":85},"Patrik Johansson, MD, MPH","CONTACT","206-708-8623","patrik.johansson@wsu.edu",{"name":87,"role":83,"phone":88,"email":89},"Odile Z Madesclaire, MPH","206-708-8617","odile.madesclaire@wsu.edu",{"name":82,"role":91},"PRINCIPAL_INVESTIGATOR",{"lat":93,"lon":94},47.60621,-122.33207,[96,97],{"name":82,"role":83,"phone":84,"email":85},{"name":87,"role":83,"phone":88,"email":89},[],[],[],{"nct_id":4,"conditions":102,"biomarkers":106},[103,104,105],"Alzheimer's Disease","Dementia","Mild cognitive disorder",[],{"nct_id":4,"found":14,"summary":108,"prompt_version":118},{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This study is a group-randomized trial involving 28 clinics. Clinics will be randomly assigned to either receive the INTACT program immediately or be placed on a wait-list.","completed","INTACT Program for Alzheimer's Care Training","This study, called the Indian Transforming Alzheimer's Care Training (INTACT) program, is testing a new way to improve care for American Indian\u002FAlaska Native (AI\u002FAN) patients with Alzheimer's disease and related dementias (ADRD) or mild cognitive impairment (MCI). The program trains primary care providers (PCPs) in screening, diagnosis, and care for these conditions, and offers quarterly webinars on topics like driving and communication. The study aims to see if this training helps clinics diagnose more cases of ADRD and MCI, increases PCPs' confidence in providing care, and improves the quality of care for patients. This study is looking to enroll 28 clinics that serve AI\u002FAN patients. The current recruitment status is unclear.","Data will be collected at the beginning of the study and again after 12 months.",111,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]