Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-29 @ 12:23 AM
Study NCT ID:
NCT05483803
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Participants will be enrolled in two sub-studies. Participants in sub-study 1 will be enrolled in an intervention for 1 month. After sub-study 1 completion a new group of participants will be enrolled in the sub-study 2 for the intervention lasting 3 months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sub-study 1: Qualitative data of psychological burdens experienced as caregivers of children with type 1 diabetes and barriers/facilitators for adopting the digital health solution', 'timeFrame': '1 Month', 'description': 'A semi-structured interview based on a mental health and technology acceptance theoretical framework has been specifically designed for this purpose.'}, {'measure': "Sub-study 2: Changes on caregiver's positive mood", 'timeFrame': '3 Months', 'description': 'Positive subscale of the Positive and Negative Affect Scale (PANAS). Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.'}], 'secondaryOutcomes': [{'measure': "Emotional outcome: Changes on caregiver's distress", 'timeFrame': 'Baseline up to week 12', 'description': 'Distress assessed with the depression, anxiety, and stress scale (DASS-21). DASS-21 is a self-report questionnaire consisting of 21 items, 7 items per subscale: depression, anxiety and stress. Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores are computed by adding up the scores on the items per (sub)scale and multiplying them by a factor 2. Sum scores for the total DASS-total scale thus range between 0 and 120, and those for each of the subscales may range between 0 and 42. Cut-off scores of 60 and 21 are used for the total DASS score and for the subscales respectively. Scores ≥60 (for DASS-total) and ≥21 (for the depression subscale) are labeled as "high" or "severe".'}, {'measure': "Emotional outcome: Changes on caregiver's general wellbeing", 'timeFrame': 'Baseline up to week 12', 'description': 'Assessed with the short form of the Mental Health Continuum - short form questionnaire (MHC-SF). Total sum scores on the MHC-SF can range from 0 to 70, with higher scores indicating higher levels of well-being.'}, {'measure': "Emotional outcome: Changes on caregiver's perceived self-efficacy", 'timeFrame': 'Baseline up to week 12', 'description': 'Perceived self-efficacy assessment with the General Self-Efficacy Scale (GSE), the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.'}, {'measure': "Health-related Quality of Life (HrQoL): Changes on the child's HRQoL", 'timeFrame': 'Baseline up to week 12', 'description': 'Children HRQoL assessment with KIDSCREEN-10 index answered by the caregiver as a proxy. The scores range between 10 and 50, and are linearly converted into 0-100 scale in which higher scores represent better quality of life.'}, {'measure': 'Life-style outcome: Adherence to Mediterranean diet', 'timeFrame': 'Baseline up to week 12', 'description': 'Assessed with the KIDMED questionnaire. This questionnaire consists of 16 questions, where negative answers are scored with 0, while affirmative answers are scored with +1/-1 depending on their positive or negative connotation.'}, {'measure': 'Life-style outcome: physical activity (APALQ)', 'timeFrame': 'Baseline up to week 12', 'description': 'Physical activity assessed with Assessment Physical Activity Levels Questionnaire (APALQ). It is a self-administered questionnaire with 5 items scored 1 to 4/5, in which the sum of the answers classifies the global score in 3 categories: sedentary (5 to 10), moderately active (11-16), very active (+17).'}, {'measure': 'Knowledge of the disease and its treatment.', 'timeFrame': 'Baseline up to week 12', 'description': 'Medical checking questions related to the disease, its treatment and if the patients are following the multiple doses of insulin (MDI) or the continuous subcutaneous insulin infusion (CSII) treatment.'}, {'measure': "Behavioral outcome: objectively measured children's metabolic control to the treatment", 'timeFrame': 'Baseline up to week 12', 'description': 'Assessed from the sensor used via glucose monitoring'}, {'measure': 'Behavioral outcome: Usability', 'timeFrame': 'At week 4 (sub-study 1) or week 12 (sub-study 2)', 'description': 'mHealth solution usability assessed with the System Usability Scale (SUS) questionnaire. SUS can range between 0 and 100 scores, with higher values representing higher usability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'mhealth', 'caregiver', 'emotional health', 'behavioral intervention'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'referencesModule': {'references': [{'pmid': '32338624', 'type': 'BACKGROUND', 'citation': 'Carrasco-Hernandez L, Jodar-Sanchez F, Nunez-Benjumea F, Moreno Conde J, Mesa Gonzalez M, Civit-Balcells A, Hors-Fraile S, Parra-Calderon CL, Bamidis PD, Ortega-Ruiz F. A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 27;8(4):e17530. doi: 10.2196/17530.'}]}, 'descriptionModule': {'briefSummary': 'This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a mobile-based novel digital health solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children with type I diabetes (T1D).\n\nThe digital health program, called Adhera® Caring, is designed to be used for approximately 3 months. The study will enroll 100 participants (20 in sub-study 1 and 80 in sub-study 2) who are caregivers of children with type 1 diabetes. There will be a nurse coaching the participants by providing support related to their emotional wellbeing via the mobile solution.', 'detailedDescription': 'Objectives:\n\n* Primary objective 1. To gather qualitative and quantitative information enabling to better understand psychological burdens that caregivers of children with type 1 diabetes and perceived barriers/facilitators for adoption of a digital health solution.\n* Primary objective 2. To assess positive mood states of caregivers of type 1 diabetes patients as an indicator of emotional wellbeing related to the use of the digital health solution.\n\nThis is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies:\n\n* Qualitative sub-study 1 (SS1): One group of caregivers (n = 20) will engage with the digital health solution for 1 month. Subsequently, an individual semi-structured interview with each of the participants and a usability questionnaire will proceed to gather user experience qualitative information.\n* Quantitative sub-study 2 (SS2): A different group of caregivers (n = 80) will engage with the digital health solution for 3 months. As elaborated in the following sections, a quantitative approach will be adopted to assess different emotional and behavioral parameters before and after engaging with the digital health solution (pre-post design).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Caregiver of patients with type 1 diabetes under 18 years of age.\n* Patient's debut of type 1 diabetes at least 3 months prior to the start of the study.\n* Patients with continuous glucose monitoring.\n* Participants with children undergoing insulin treatments (multiple dose insulin or continuous subcutaneous insulin infusion)\n* Participants administering insulin treatment to their children\n* Users of smartphone whose children are treated with type 1 diabetes treatment for approved indications in Spain.\n* Participants must agree on sharing data on continuous glucose monitoring data of their treated children.\n* Participants must sign an informed consent\n* Participants must be willing to and install the mobile solution of the study.\n\nExclusion Criteria:\n\n* Candidates without a smartphone or not being able to interact with it.\n* Only one legal guardian per child can participate in the study.\n* Participants of SS1 will not take part in SS2."}, 'identificationModule': {'nctId': 'NCT05483803', 'acronym': 'CARING-T1D', 'briefTitle': 'Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adhera Health, Inc.'}, 'officialTitle': 'CARING: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'CAR-22-001'}, 'secondaryIdInfos': [{'id': 'U1111-1280-9100', 'type': 'REGISTRY', 'domain': 'WHO Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Qualitative sub-study 1 group', 'description': 'One group of caregivers (n = 20) will engage with the digital health solution during 1 month.', 'interventionNames': ['Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes']}, {'type': 'EXPERIMENTAL', 'label': 'Quantitative sub-study 2 group', 'description': 'A different group of caregivers (n = 80) will engage with the digital health solution during 3 months.', 'interventionNames': ['Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes']}], 'interventions': [{'name': 'Adhera® Caring digital intervention for Type 1 Diabetes', 'type': 'BEHAVIORAL', 'description': 'The Adhera® Caring is a mobile based personalized digital intervention for caregivers, lasting for 1 or 3 months (depending on the sub-study).', 'armGroupLabels': ['Qualitative sub-study 1 group', 'Quantitative sub-study 2 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50009', 'city': 'Zaragoza', 'state': 'Aragon', 'country': 'Spain', 'facility': 'Hospital Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Antonio de Arriba Muñoz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidad de Endocrinología Pediátrica, Hospital Miguel Servet'}, {'name': 'Luis Fernandez Luque, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adhera Health, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adhera Health, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital Miguel Servet', 'class': 'OTHER'}, {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}