Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT06628856
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2024-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life of the Piloted Individuals and a Cost-efficiency Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011788', 'term': 'Quality of Life'}], 'ancestors': [{'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative analysis', 'timeFrame': '5 MONTHS', 'description': 'structured interviews: The coding system for the qualitative information will be carried out using the Atlas-Ti content analysis program. Atlas-Ti allows exporting a matrix to SPSS format, as a quantitative data matrix composed of the set of ideas, identified by the code of each interview, the idea number and its corresponding code for affected person and family member. In this way, the frequencies of the different categories can be analyzed.'}, {'measure': 'Multilevel analysis', 'timeFrame': '5 MONTHS', 'description': 'daily records: Multilevel analyses will be performed by applying Mix Models with maximum likelihood (ML) estimation.'}, {'measure': "Student's t-tests", 'timeFrame': '5 MONTHS', 'description': "telematic records: Student's t-tests for independent samples and ANOVAs/ANCOVAs will be applied to analyze differences in the study variables (needs, QOL, coping strategies) according to sociodemographic (sex, age, educational level) and clinical variables (type of disease, type of treatment or dependency status)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Person-centred care', 'meaningful activities', 'direct care professional', 'occupational therapist'], 'conditions': ['Terminal Illness']}, 'descriptionModule': {'briefSummary': 'The increasing life expectancy and global aging population necessitate changes in long-term gerontological services based on Person-Centred Care approaches. This study aims to improve Person-Centred Care in geriatric centers through meaningful activities and the role of occupational therapists and direct care professionals in developing these activities. A descriptive cross-sectional quasi-experimental design was proposed, with 10 participants.', 'detailedDescription': 'Background: Increasing life expectancy means that the ageing of populations globally is on the rise. It is therefore important to promote changes in long-term gerontological services based on Person-Centred Care approaches, in which meaningful occupation serves as a basis and is supported by appropriate professional support, such as the occupational therapist and the direct care professional.\n\nObjective: The study aims to analyze the needs, quality of life, and coping strategies of terminally ill patients over five months, as well as burnout and dehumanization among caregivers and healthcare staff.\n\nMethods: This study examines factors influencing the quality of life (QOL) of terminally ill patients and the burnout and dehumanization of caregivers and health professionals using a mixed methodology. The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* That the direct care worker has a degree as a nursing assistant, dependency care technician, geroculturist or certificate of professionalism.\n* The worker must speak and understand Spanish.\n* The residence must offer service during the day, in the morning or afternoon shift.\n* Workers must have been with the department for more than 4 months.\n\nExclusion Criteria:\n\n* Workers who work night shift only.\n* Workers on rotating shifts in all departments of the residence.\n* Workers absent at the time of the study due to temporary leave, vacations or other causes.'}, 'identificationModule': {'nctId': 'NCT06628856', 'briefTitle': 'Quality of Life of the Piloted Individuals and a Cost-efficiency Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Burgos'}, 'officialTitle': 'Ex Ante and Interim Evaluation of the Quality of Life of the Piloted Persons, and Cost-efficiency Analysis', 'orgStudyIdInfo': {'id': 'ACP 2/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HOSPITAL CHILE', 'description': 'The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being. (N=286)', 'interventionNames': ['Other: Quality of life']}, {'type': 'EXPERIMENTAL', 'label': 'HOSPITAL SPAIN', 'description': 'The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being. (N=286)', 'interventionNames': ['Other: Quality of life']}], 'interventions': [{'name': 'Quality of life', 'type': 'OTHER', 'description': 'The study proposes a 3-time longitudinal design, with evaluations at baseline, 2.5 months, and 5 months, to measure the impact of an intervention on terminally ill patients and their families, focusing on health status, quality of life, and emotional well-being.', 'armGroupLabels': ['HOSPITAL CHILE', 'HOSPITAL SPAIN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09003', 'city': 'Burgos', 'state': 'Burgos', 'country': 'Spain', 'facility': 'Olalla Saiz Vazquez', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Burgos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}