Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT02471794
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2015-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Health Planning in Shared Medical Appointments for Individuals With Type II Diabetes Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2015-06-11', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility measured using a patient satisfaction survey', 'timeFrame': '12 months'}, {'measure': 'Change in patient activation measured using the patient activation measure', 'timeFrame': 'baseline; 6 months; 12 months'}, {'measure': 'Change in self-management of diabetes self-efficacy using the Diabetes Empowerment Scale', 'timeFrame': 'baseline; 6 months; 12 months'}, {'measure': 'Change in diabetes self efficacy using the 1-item diabetes self-efficacy scale', 'timeFrame': 'baseline; 6 months; 12 months'}, {'measure': 'Change in A1C using the A1C blood test', 'timeFrame': 'baseline; 3 months; 6 months; 9 months; 12 months'}], 'secondaryOutcomes': [{'measure': 'Change in depression screening score using the Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'baseline; 6 months; 12 months'}, {'measure': 'Change in functional health and well-being using the short form health survey', 'timeFrame': 'baseline; 6 months; 12 months'}, {'measure': 'Change in general self-rated health using the general self rated health survey (GSRH)', 'timeFrame': 'baseline; 6 months; 12 months'}, {'measure': 'Change in health goal progress using a goal progress visual analog scale', 'timeFrame': '3 months; 10 months'}, {'measure': 'change in body mass index using weight and height measurements', 'timeFrame': 'baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months'}, {'measure': 'change in blood pressure using blood pressure measurement', 'timeFrame': 'baseline; 1 months; 2 months; 3 months; 5 months; 8 months; 10 months; 12 months'}, {'measure': 'Change in low-density lipoprotein cholesterol (LDL) using LDL measurement', 'timeFrame': 'baseline; 6 months; 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type II Diabetes', 'Personalized Health Planning', 'Shared Medical Appointments'], 'conditions': ['Type II Diabetes']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to examine the feasibility of implementing an evidence based patient engagement strategy, known as personalized health planning (PHP), in the context of a a shared medical appointment (SMA) for individuals with type II diabetes in a primary care setting.', 'detailedDescription': 'All data for the prospective portion of this study was done being collected in September 2016. The retrospective chart review will collect data up until March of 2017 (six months after the last subject completed the prospective phase by attending their last SMA session).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of Type 2 diabetes within the last year\n* A current patient at Duke Family Medicine.\n* An A1C score greater than 7 and less than 14.\n\nExclusion Criteria:\n\n* A diagnosis of Pre-diabetes\n* A diagnosis of Type I diabetes\n* Individuals with amputations as a result of their diabetes are excluded form this study.\n* Individuals with renal dialysis will not be included in this study.'}, 'identificationModule': {'nctId': 'NCT02471794', 'briefTitle': 'Personalized Health Planning in Shared Medical Appointments for Individuals With Type II Diabetes Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Personalized Health Planning in Shared Medical Appointments for Individuals With Type II', 'orgStudyIdInfo': {'id': 'Pro00063493'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Shared Medical Appointment', 'description': 'The SMA group will be a standard shared diabetes medical appointment group consisting of up to 10 patients that utilizes the design and curriculum of the SMAs that are currently being held at the Duke Family Medicine Center.'}, {'type': 'EXPERIMENTAL', 'label': 'Personalized Health Planning Shared Medical Appointment', 'description': "The PHP SMA group will combine personalized health planning with a modified version of the standard shared diabetes medical appointment. Modifications include: a self-assessment of health status, greater emphasis on a collaborative patient-provider health goal-setting process, a plan to meet goals, a mindfulness practice included in each session, and the creation of a 'personalized health plan' participant notebook for each individual to document health goals and track progress to review at each session. The participant notebook also includes educational handouts and worksheets to complement the educational curriculum.", 'interventionNames': ['Behavioral: Personalized Health Planning Shared Medical Appointment']}, {'type': 'NO_INTERVENTION', 'label': 'Retrospective', 'description': "A retrospective chart review will be conducted once all participants (both SMA group and PHP SMA group) complete the intervention. The retrospective chart review will collect healthcare utilization data six months prior, during, and after each subject's participation in the SMA."}], 'interventions': [{'name': 'Personalized Health Planning Shared Medical Appointment', 'type': 'BEHAVIORAL', 'description': "The PHP SMA group will combine personalized health planning with a modified version of the standard shared diabetes medical appointment. Modifications include: a self-assessment of health status, greater emphasis on a collaborative patient-provider health goal-setting process, a plan to meet goals, a mindfulness practice included in each session, and the creation of a 'personalized health plan' participant notebook for each individual to document health goals and track progress to review at each session. The participant notebook also includes educational handouts and worksheets to complement the educational curriculum", 'armGroupLabels': ['Personalized Health Planning Shared Medical Appointment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Family Medicine Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Sharon Hull, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}