Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-02 @ 2:34 AM
Study NCT ID:
NCT05994651
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2023-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Tidal Model in Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-08', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. The effect of using the tidal model on the distress status of individuals with diabetes will be evaluated.', 'timeFrame': 'up to 6-10 weeks', 'description': 'The DDS is a 17-item psychological measurement tool that uses a Likert scale with each item scored from 1 (no distress) to 6 (serious distress) to reflect distress experienced over the last month. The total score is calculated by dividing the sum of the answers by 17. A score of ≥3 is defined as T2DM-related distress. There are four subscales and subscale scores are also calculated by dividing the sum of subscale answers to the total question count of the subscale. Subscales are as follows: the emotional burden subscale with 5 questions, the physician-related distress subscale with 4 questions, the regimen-related distress subscale with 5 questions, and the interpersonal distress subscale with 3 questions.'}, {'measure': 'The effect of using the tidal model on the self-management status of individuals with diabetes will be evaluated.', 'timeFrame': 'up to 6-10 weeks', 'description': 'There are 8 items in the original scale of the Diabetes Self-Management Perception Scale. High participation in these items indicates low self-efficacy. For this reason, the 3 items mentioned were reverse scored compared to the other items. The lowest score that can be obtained from the scale is 7, and the highest score is 35. A high total score indicates that the individual has good awareness of diabetes management'}, {'measure': 'The effect of using the tidal model on the psychological well-being of individuals with diabetes will be evaluated.', 'timeFrame': 'up to 6-10 weeks', 'description': 'The scale is an 8-item 7-point Likert-type (1=totally disagree, 7=totally agree) self-assessment scale. High scores indicate higher psychological well-being.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes disease', 'Psychiatric Nursing', 'Tidal Model', 'Psychological well-being', 'Distress', 'Self-Management'], 'conditions': ['Diabetic']}, 'descriptionModule': {'briefSummary': 'Aim:\n\nIn this study, it was aimed to evaluate the effect of the tidal model on distress, self-management and psychological well-being in individuals with diabetes. It is thought that this study will contribute to the literature, nursing profession and patients with diabetes.', 'detailedDescription': "Population of the Research: The population of the research will be individuals who applied to Osmaniye State Hospital and were diagnosed with Diabetes at least 6 months ago. The sample of the research: The sample of the research is; In calculating the number of samples, the study of Savaşan and Çam named 'The Effect of the Psychiatric Nursing Approach Based on the Tidal Model on Coping and Self-esteem in People with Alcohol Dependency: A Randomized Trial' was taken as reference.At the end of the Tidal Model application, the effect size was calculated as 0.652 based on the difference between the self-esteem scores. In this context; A power of 0.80 and a margin of error of 0.05 for type 1 were taken, and it was deemed appropriate to take a total of 60 individuals, with a sample size of 30 individuals in the intervention and control groups. Sample size is based on independent t-test. It was decided to include more than 20% of the sample number calculated in terms of losses during the implementation of the study and statistical analysis. Accordingly, 36 intervention and 36 control groups will beResearch data\n\nLiterature-based Personal Information Form will be collected using Diabetes Distress Scale Type 2 Diabetes Self-Management Scale Psychological Well-Being Scale. In order to conduct the study, the approval of the Clinical Research Ethics Committee, written permission from the institution and written permission from the participants were obtained.In the study, in which the psychiatric nursing approach based on the Tidal Model is applied, approximately 6 and 10 individual interviews will be held with the individuals in the experimental group in addition to the routine treatment and follow-up in the Osmaniye State Hospital training hall. The control group will continue to receive routine treatment and follow-up. In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the objectives of the research. Considering the basic processes of the Tidal Model, stages of care, basic approach and Tidal competencies, an interview plan including the details of the interviews with diabetes patients will be created and a meeting plan will be made with One-to-One Sessions. It will be concluded with an average of 6 and 10 interviews, depending on the situation of the individuals. tried to be formed. The number of samples was calculated in the G\\*Power 3.1 program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosed with diabetes for at least 6 months, Individuals aged 18 and over will be included in the study.\n\nExclusion Criteria:\n\nPatients with any psychiatric or neurological disorder that would prevent adequate communication will not be included in the study.'}, 'identificationModule': {'nctId': 'NCT05994651', 'briefTitle': 'The Effect of the Tidal Model in Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Osmaniye Korkut Ata University'}, 'officialTitle': 'Evaluation of the Effect of Tidal Model on Distress, Self-Management and Psychological Well-Being in Individuals With Diabetes', 'orgStudyIdInfo': {'id': 'Tidal Model'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tidal Model improvement model', 'description': 'In order to provide individualized care to the individuals in the experimental group, initiatives will be implemented by starting individual interviews and in line with the goals of the individuals and the research objectives.', 'interventionNames': ['Behavioral: Tidal Model improvement model']}, {'type': 'NO_INTERVENTION', 'label': 'Tidal Model Control Group', 'description': 'Individuals in the control group will continue their lives.'}], 'interventions': [{'name': 'Tidal Model improvement model', 'type': 'BEHAVIORAL', 'description': '1. st interview Pre-assessment Application of measurement tools\n2. nd meeting Orientation Concept of recovery, change phase of the individual, Holistic Evaluation, Creation of Personal Safety Plan 3. Interview Process planning Setting goals, Starting One-on-One Sessions\n\n4th meeting Healing is possible, accepting his illness, overcoming change, emphasizing his strengths, instilling hope 5.-6. interview Empowerment Coping with crisis, reducing anxiety, relaxation exercises, individual roles, assertiveness, strengthening self-esteem 7.-8. Interview Maintaining control of life, taking responsibility for behavior, appropriate expression of anger, feeling, thinking and Taking responsibility for recovery, discovering behaviors 9th interview Creating a supportive environment Increasing new interactions, relationships, social skills 10th meeting Evaluation Finalizing the personal security plan, using new knowledge and behaviors in the healing journey, evaluation of the process', 'armGroupLabels': ['Tidal Model improvement model']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Osmaniye', 'state': 'Korkut Ata University', 'country': 'Turkey (Türkiye)', 'facility': 'Türkiye', 'geoPoint': {'lat': 37.07417, 'lon': 36.24778}}], 'overallOfficials': [{'name': 'Ejdane Coşkun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korkut Ata University Osmaniye, Center, Türkiye, 80000'}, {'name': 'Ayşe İNEL MANAV', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korkut Ata University Osmaniye, Center, Türkiye, 80000'}, {'name': 'Derya Atik', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korkut Ata University Osmaniye, Center, Türkiye, 80000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Don't share"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osmaniye Korkut Ata University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ejdane Coskun', 'investigatorAffiliation': 'Osmaniye Korkut Ata University'}}}}