Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-02 @ 3:26 AM
Study NCT ID:
NCT04819256
Status:
TERMINATED
Last Update Posted:
2022-04-28
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Care Based Integrated Community Care Team Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'whyStopped': 'Funding diverted to expansion of programme and PACE-It App', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '1 year', 'description': 'Glycemic control'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '1 year', 'description': 'Systolic and diastolic blood pressure (mmHg)'}, {'measure': 'LDL-cholesterol', 'timeFrame': '1 year', 'description': 'Low-density lipoprotein cholesterol'}, {'measure': 'Patient activation measure (PAM)', 'timeFrame': '1 year', 'description': "Patient's activation levels"}, {'measure': 'Medication adherence measure (MARS-5)', 'timeFrame': '1 year', 'description': "Patient's adherence to medication"}, {'measure': 'EQ-5D-5L', 'timeFrame': '1 year', 'description': 'Quality of life'}, {'measure': 'Patient satisfaction', 'timeFrame': '1 year', 'description': 'Qualitative survey and interview'}, {'measure': "Provider's satisfaction", 'timeFrame': '2 years', 'description': 'Qualitative survey and interview'}, {'measure': 'Cost-effectiveness', 'timeFrame': '2 years', 'description': 'Cost-effectiveness of care model'}, {'measure': 'Implementation of care model', 'timeFrame': '2 years', 'description': 'Factors affecting implementation of care model'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Diabetes type2']}, 'descriptionModule': {'briefSummary': 'PACE-It study is a non-blinded, mix-method randomized controlled trial within a single site. This study aims to test the feasibility of implementing a complex intervention comprising of a) a Primary Care Based integrated community care team delivery of person centered care, b) supported by a care co-ordination platform using a mobile application and its effectiveness in improving the glycemic control of patients living with Diabetes and have complex needs.', 'detailedDescription': 'PACE-It study aims to test the feasibility of implementing a complex intervention comprising of a) a Primary Care Based Community Care Team delivery of person centered care b) supported by a care co-ordination platform using a mobile application and its effectiveness in improving the glycemic control of patients living with Diabetes and complex needs.\n\nThis is a non-blinded, mix-method randomised controlled trial within the Marine Parade Community. The primary outcome will be glycemic control measure by the Glycated Haemoglobin (HbA1c). Secondary outcomes include blood pressure, LDL-cholesterol, Patient Activation Measure, Medication Adherence and Quality of Life. Data on patient and provider satisfaction and implementation process will be collected by the Qualitative method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living within the designated geographical zone\n* 50 years and above\n* Satisfy the Medical Criteria below:\n\n 1. Diabetes with HbA1c ≥ 9% (within past 6 months), and\n 2. At least 1 complication\n\n 1. chronic kidney impairment stage 3 and above, or diabetes overt nephropathy,\n 2. ischaemic heart disease, or congestive cardiac failure,\n 3. peripheral arterial disease, or diabetes foot/ diabetes foot-related complications,\n 4. diabetic retinopathy/ treatment for retinopathy, and\n 5. stroke, or transient ischaemic attack\n* Satisfy at least 2 conditions in the psycho-social, functional or activation domain of which 1 criteria must be from the psycho-social domain:\n\n 1. Psycho-social issues\n\n a. Lack of care giver support i. No care-giver (when indicated) ii. Care-giver skills gap/ stress iii. Inability of copy when patient is the care-giver b. Difficult relationships (family/ workplace/ social network) c. Social isolation/ lack of social connectivity i. Lives alone ii. Lack of social network support d. Financial i. Financial difficulty/ insecurity ii. Housing/ shelter issues iii. Poor money management\n 2. Functional\n\n 1. Clinical Frailty Score ≥ 4, requiring help in instrumental activities of daily living (iADL)\n 2. Requires assistance in ADL or iADL\n 3. Activation a. Lack of ability to manage health - disengaged or overwhelmed i. Anxiety or disease-related distress ii. Confusion or lack of understanding of care plans iii. Non-adherence to medications/ follow up\n* Patient gives consent to participate\n* For patients who may be seeing a Primary Care Physician (PCP) outside of the polyclinic for chronic disease management and where the PCP has indicated consent to co-manage the patient with the PACE-It team including the polyclinic physician\n* Patient must be willing to receive care in the polyclinic\n\nExclusion Criteria:\n\n* Patients who are on follow up with Primary Care Physicians or General Practitioners elsewhere for management of their chronic conditions and they do not consent to co-managing patient with the PACE-It team\n* Patients who have severe cognitive impairment, depression or psychiatric conditions that interfere with the ability to engage with the healthcare team\n* Patients who are (i) not community ambulant or (ii) bed bound\n* Patients with terminal illness\n* Patients who have are in other programs or research studies\n* Patients who do not give consent'}, 'identificationModule': {'nctId': 'NCT04819256', 'acronym': 'PACE-It', 'briefTitle': 'Primary Care Based Integrated Community Care Team Intervention', 'organization': {'class': 'OTHER', 'fullName': 'SingHealth Polyclinics'}, 'officialTitle': 'PACE-It Study : Primary Care Based Integrated Community Care Team Intervention to Improve the Health Outcomes of Patients Living With Diabetes and Complex Needs - a Feasibility Study', 'orgStudyIdInfo': {'id': '2020/2202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Providers use PACE-It mobile application as a care co-ordination platform', 'interventionNames': ['Other: PACE-It mobile application']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Providers use usual modes of communication (e.g., phone calls, emails)'}], 'interventions': [{'name': 'PACE-It mobile application', 'type': 'OTHER', 'description': 'Care co-ordination platform', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '440080', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'SingHealth Polyclinics - Marine Parade, 80 Marine Parade Central, #01-792', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Sinead Zhen Wang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SingHealth Polyclinics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SingHealth Polyclinics', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Singapore', 'class': 'OTHER_GOV'}, {'name': 'Agency for Integrated Care, Singapore', 'class': 'OTHER'}, {'name': 'SingHealth Regional Health System', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}