Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
Study NCT ID:
NCT04131257
Status:
UNKNOWN
Last Update Posted:
2019-10-18
First Post:
2019-10-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], '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'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1236}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-16', 'studyFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycated Hemoglobin (HbA1c) level', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'The HbA1c will be measured using Boronate affinity chromatography (Axis-Shield, Norway)'}, {'measure': 'Change in the incidence of diabetes among individuals with pre-diabetes', 'timeFrame': '6 months, 12 months', 'description': 'Electronic Health Record will be used to measure the incidence of diabetes'}], 'secondaryOutcomes': [{'measure': 'Change in Blood Pressure', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'The blood pressure will be measured using mean of three measurements of systolic and diastolic blood pressure, using a Microlife automatic blood pressure measuring device'}, {'measure': 'Change in lipid profile levels (HDL, LDL, Triglycerides, Total cholesterol)', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'LDL and HDL will be measured using the elimination method (Dialab, Austria); triglyceride using GPO-PAP (Dialab, Austria); and total cholesterol using CHOD-PAP (Dialab, Austria)'}, {'measure': 'Change in Body Mass Index', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Body Mass Index will be calculated as weight in kilograms divided by height in meters squared'}, {'measure': 'Change in the "Reach" of people participating in the program', 'timeFrame': '6 months, 12 months', 'description': 'Reach will be measured by the number of people participating in the program divided by the number of people eligible to be recruited into the program'}, {'measure': 'Change in the "Adoption at the patient level" measured by the Summary of Diabetes Self-Care Activities Scale', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Adoption at the patient level will be measured by the proportion of people adherent to the clinical advice in lifestyle and self-care. These will be measured by the self-reported Summary of Diabetes Self-Care Activities scale. Five areas are assessed by the scale: Diet, Exercise, Blood-glucose testing, Foot care, and Smoking status. Scale of 0-7 is used. Higher the score better is the outcome.'}, {'measure': 'Change in the "Adoption at the patient level" measured by the Diabetes Treatment Satisfaction Questionnaire', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'The Diabetes Treatment Satisfaction Questionnaire will be used to measure patient perception of the treatment. It is composed of eight questions, each of which is scored by patients on a scale ranging from zero (e.g., "very dissatisfied", "very inconvenient") to six (e.g., "very satisfied", "very convenient"). More satisfied the patient, better is the outcome.'}, {'measure': 'Change in the "Adoption at the clinic level"', 'timeFrame': '6 months, 12 months', 'description': "Adoption at the clinic level will be measured by a number of participants served using health records and examining nurses' adoption of intervention program through interviews"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Continuum of care', 'Diabetes', 'Pre-diabetes'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '32471476', 'type': 'DERIVED', 'citation': 'Xu DR, Dev R, Shrestha A, Zhang L, Shrestha A, Shakya P, Hughes JP, Shakya PR, Li J, Liao J, Karmacharya BM. NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial. Trials. 2020 May 29;21(1):442. doi: 10.1186/s13063-020-04372-5.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.', 'detailedDescription': 'The purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in Nepal.\n\nWe will conduct a two-arm, open-masked stratified cluster randomized controlled trial of a NUrse-led COntinuum of care for people with diabetes and pre-diabetes (NUCOD), with primary care centers (Outreach centers and Government health posts) as a unit of randomization. NUCOD will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the enhanced usual-treatment group at 6 and 12 months of the intervention. The primary outcome will be change in glycated hemoglobin (HbA1c) level among diabetes and progression to type 2 diabetes among pre-diabetes, and implementation outcomes measured using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Outcomes will be analyzed on an intention to treat basis.\n\nThe results of this trial will provide information about the effectiveness of the NUCOD program in improving clinical outcomes for diabetes and pre-diabetes individuals, and implementation outcomes for the organization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with confirmed pre-existing type II diabetes and prediabetes at the time of our screening (i.e., pre-existing diabetes or prediabetes)\n* with confirmed diagnosis of type II diabetes or prediabetes after our community screening process (i.e., newly diagnosed diabetes and prediabetes)\n* is not planning to relocate outside of the current place of living in next 2 years\n* is older than 18 years of age\n\nExclusion Criteria:\n\n* are not psychologically capable of communication\n* are diagnosed as type 1 diabetes'}, 'identificationModule': {'nctId': 'NCT04131257', 'acronym': 'NUCOD', 'briefTitle': 'Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal', 'organization': {'class': 'OTHER', 'fullName': 'Kathmandu University School of Medical Sciences'}, 'officialTitle': 'Nurse-led Continuum of Care for People With Diabetes and Pre-diabetes in Nepal (NUCOD): Study Protocol for a Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KathmanduUSMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuum of care', 'description': 'Trained diabetes nurses will provide continuum of care to the participants that includes: conducting community awareness campaigns, screening programs, linkage to clinical care, community follow-up counseling and support for individuals with diabetes, and prevention programs for individuals with pre-diabetes.', 'interventionNames': ['Behavioral: Nurse-led Continuum of Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'The control group will receive usual diabetic care without the nurse coordination and supervision as in the intervention group.', 'interventionNames': ['Behavioral: Nurse-led Continuum of Care']}], 'interventions': [{'name': 'Nurse-led Continuum of Care', 'type': 'BEHAVIORAL', 'description': 'This will be a nurse-led community level prevention program for individuals with diabetes and pre-diabetes, where participants in intervention group will receive nurse-led continuum of care while control group will receive usual diabetic care.', 'armGroupLabels': ['Continuum of care', 'Usual care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Biraj M Karmacharya', 'role': 'CONTACT', 'email': 'birajmk@gmail.com', 'phone': '+977 9802000029'}, {'name': 'Rubee Dev', 'role': 'CONTACT', 'email': 'meetrubss@hotmail.com', 'phone': '+86 15521049506'}], 'overallOfficials': [{'name': 'Biraj M Karmacharya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kathmandu University School of Medical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available within 6 months of study completion.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome will be made available.', 'accessCriteria': 'Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kathmandu University School of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Biraj Man Karmacharya', 'investigatorAffiliation': 'Kathmandu University School of Medical Sciences'}}}}