Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 1:13 AM
Study NCT ID:
NCT07473050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Score of the Diabetic Foot Knowledge Scale', 'timeFrame': 'Baseline, 1 month post-intervention, and 3 months follow-up', 'description': "The outcome is the change in the total score of the Diabetic Foot Knowledge Scale (DFKS). The scale assesses participants' knowledge regarding diabetic foot care. Scores are calculated by summing item responses, with higher scores indicating greater knowledge. The change in total score will be calculated by comparing baseline (pre-test), 1-month post-intervention, and 3-month follow-up assessments."}], 'secondaryOutcomes': [{'measure': 'Change in Total Score of the Diabetic Foot Health Nurse Follow-up Form', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in the total score of the Diabetic Foot Health Nurse Follow-up Form between baseline and 3 months. The form evaluates clinical foot health through nurse assessment of several domains including skin integrity, presence of lesions, sensory status, and nail condition. Scores are calculated by summing the item scores, with higher scores indicating poorer foot health status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic foot', 'Foot care', 'Virtual Reality', 'nursing', 'nursing care'], 'conditions': ['Diabetic Foot - Telemedical Monitoring', 'Diabetic', 'Foot Care', 'Virtual Reality']}, 'descriptionModule': {'briefSummary': 'This randomized controlled experimental study aims to develop and evaluate the effectiveness of a Virtual Reality-Based "Health to My Foot" program designed for individuals with Type II Diabetes Mellitus. The study will assess the program\'s impact on diabetic foot knowledge, foot care self-efficacy, foot care behaviors, and foot health outcomes.\n\nThe research will be conducted between April and October 2026 at a university hospital diabetes outpatient clinic in İzmir, Türkiye. A total of 70 participants diagnosed with Type II DM will be enrolled and randomly assigned to either the intervention group (n=35) or the control group (n=35) using stratified block randomization.\n\nParticipants in the intervention group will receive the Virtual Reality-Based "Health to My Foot" program through virtual reality goggles and will have access to a recorded foot care training video for home use. They will also receive weekly motivational reminder messages for three months. The control group will receive standard outpatient care only.\n\nData will be collected at baseline (pre-test), 1 month (post-test), and 3 months (follow-up) using validated scales and a nurse follow-up form to evaluate knowledge, self-efficacy, behaviors, and clinical foot health indicators. The findings are expected to contribute to sustainable patient education strategies and to support the prevention of diabetic foot complications and reduction of healthcare costs.', 'detailedDescription': 'The goal of this study: To develop a Virtual Reality-Based "Health to My Foot" program for individuals with Type II DM and to evaluate the effect of the program on individuals\' diabetic foot knowledge, foot care self-efficacy, foot care behaviors, and foot health.\n\nStudy type: A randomized controlled experimental study The question of this study: Does the Virtual Reality-Based "Health to My Foot" program have an effect on the Diabetic Foot Knowledge, Diabetic Foot Care Self-Efficacy, Foot Care Behavior, and Foot Health of Individuals with Type II Diabetes?\n\nThe hypotheses of this study:\n\nHypothesis 1. H1: The increase in Diabetic Foot Knowledge Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.\n\nHypothesis 2. H1: The increase in Diabetic Foot Care Self-Efficacy Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.\n\nHypothesis 3. H1: The increase in Foot Care Behavior Scale scores over time (pre-test - post-test - follow-up) in individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied is statistically significantly higher compared to the control group.\n\nHypothesis 4. H1: The Diabetic Foot Health Nurse Follow-up examination data (skin condition, sensory findings, etc.) and risk classification status (low risk, medium risk, high risk) of individuals in the intervention group to whom the Virtual Reality-based "Health to My Foot" program is applied are statistically significantly more positive compared to the control group.\n\nStudy Design: The study will be conducted between April-October 2026 at the Diabetes Outpatient Clinic of the Division of Endocrinology and Metabolic Diseases, Department of Internal Medicine, Ege University Health Application and Research Center in İzmir, Türkiye.\n\nParticipants: The population of the study will consist of all individuals diagnosed with Type II DM who apply to the specified institution. The sample of the study will consist of individuals with DM selected from the specified population between December 2025 and December 2026, who meet the inclusion criteria and agree to participate in the study. A power analysis was conducted to determine the number of patients to be included in the research sample. The power analysis was performed using GPower V 3.1.9.4. In line with the information obtained from studies in the literature, a repeated measures approach was used. Accordingly, for an effect size of f = 0.30, with α = 0.05 error and 80% power, the minimum total sample size required in two groups was calculated as 62 (with a minimum of 31 patients in each group). Considering group homogeneity and possible patient losses, the study is planned to be conducted with a total of 70 patients (experimental: 35, control: 35).\n\nRandomization will be performed to ensure homogeneous distribution of the study groups. For this purpose, a stratified block randomization method will be used in terms of age, gender, and the pre-test mean score of the Foot Care Behavior Scale. Participants will be stratified according to age (18-45 / 46-65+), gender (female/male), and Foot Care Behavior Scale pre-test score (≥45 / \\<45).\n\nTo ensure allocation concealment, the "Sequentially Numbered, Opaque, Sealed Envelopes" (SNOSE) method will be used. The randomization schedule will be created via computer software by an independent person not directly involved in the study, and the sealed envelopes prepared according to this schedule will be opened sequentially after the participant is included in the study and the pre-test assessment is completed. Thus, the researcher\'s prior knowledge of which group (intervention or control) the next participant will be assigned to and the creation of selection bias will be prevented.\n\nIn the study, blinding cannot be performed because the researchers will know the groups in which the individuals are included. However, blinding will be applied in data analysis to minimize measurement bias. In the dataset, the groups will be coded as "Group A" and "Group B" and analyzed by an independent biostatistics expert who does not know which group received the intervention.\n\nThe population of the study will consist of all individuals diagnosed with Type II DM who apply to the specified institution. The sample of the study will consist of individuals with DM selected from the specified population between December 2025 and December 2026, who meet the inclusion criteria and agree to participate in the study. A power analysis was conducted to determine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years of age\n* Having been diagnosed with type 2 diabetes for at least one year\n* Having a risk level of 0, 1, or 2 according to the International Working Group on the Diabetic Foot (IWGDF) Risk Level Classification\n* Having completed primary education or higher\n* Not having hearing, speech, or visual impairments\n* Being able to use a smartphone\n* Not having received prior training in diabetic foot care\n* Being willing to participate in the study\n\nExclusion Criteria:\n\n* Having previously had a diabetic foot ulcer or currently having a diabetic foot ulcer\n\n \\- Risk level 3 according to the International Working Group on the Diabetic Foot (IWGDF) Risk Level Classification\n* Having a severe/uncontrolled comorbid disease\n* Wishing to withdraw from the study'}, 'identificationModule': {'nctId': 'NCT07473050', 'briefTitle': "Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes", 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': "Virtual Reality-Based 'Health at My Feet' Program for Individuals With Type 2 Diabetes: A Randomized Controlled Study", 'orgStudyIdInfo': {'id': '26-2.1T/32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group will not receive any intervention and will receive their routine care and treatment.'}, {'type': 'EXPERIMENTAL', 'label': 'Study', 'description': 'This group will receive VR-based intervention and will receive their routine care and treatment.', 'interventionNames': ['Behavioral: "Health for My Feet" virtual reality program.']}], 'interventions': [{'name': '"Health for My Feet" virtual reality program.', 'type': 'BEHAVIORAL', 'description': 'In addition to their routine treatment and monitoring, individuals in this group will be included in the "Health for My Feet" virtual reality program.', 'armGroupLabels': ['Study']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Prof', 'investigatorFullName': 'Aslı KALKIM', 'investigatorAffiliation': 'Ege University'}}}}