Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-24 @ 6:25 PM
Study NCT ID:
NCT06813794
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-07
First Post:
2025-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Message Framing in Diabetic Foot Self-Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2025-01-13', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetic Foot Care Self-Sufficiency Level', 'timeFrame': '3 months', 'description': 'Diabetic Foot Care Self-Efficacy Scale will be applied to the patients in Experimental Group 1, Experimental Group 2 and Control Group 3.\n\nPrimary Outcome: Change in Diabetic Foot Care Self-Efficacy Score from baseline to 3 months.\n\nMeasurement Timepoints: Baseline (Pretest) and 3-Month Follow-up (Posttest).The lowest score that can be obtained from the Diabetic Foot Care Self-Efficacy Scale is 0 and the highest score is 90. As the score obtained from the scale increases, the level of diabetic foot self-efficacy increases.'}, {'measure': 'Assessment of Foot Care Behavior', 'timeFrame': '3 month', 'description': "Foot Care Behavior Scale will be applied to the patients in Experimental Group 1, Experimental Group 2 and Control Group 3. Primary Outcome: Change in Foot Care Behavior Scale from baseline to 3 months.\n\nMeasurement Timepoints: Baseline (Pretest) and 3-Month Follow-up (Posttest).The lowest score of the Foot Care Behavior scale is 15 and the highest score is 75. The increase in the scale score indicates that the individual's self-care behaviors are better"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['message framing', 'Diabetic foot care', 'Self-efficacy'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '37059032', 'type': 'BACKGROUND', 'citation': 'Gao R, Guo H, Liu Y, Pang Y, Zhang X, Lian X, Yu T, Zhu L, Li F. The effects of message framing on self-management behavior among people with type 2 diabetes: A randomized controlled trial. Int J Nurs Stud. 2023 Jun;142:104491. doi: 10.1016/j.ijnurstu.2023.104491. Epub 2023 Mar 17.'}], 'seeAlsoLinks': [{'url': 'https://pmc.ncbi.nlm.nih.gov/articles/PMC10786793/', 'label': 'The International Working Group on the Diabetic Foot: Stories and Numbers Behind Three Decades of Evidence-Based Guidelines for the Management of Diabetes-Related Foot Disease'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess how effective gain- and loss-framed messages are in improving diabetic foot care behaviors and increasing self-efficacy levels compared to routine foot care messages.\n\nStudy Design:\n\nA randomized controlled trial with three groups:\n\nExperimental Group 1 (Gain-Framed): Participants receive gain-framed messages emphasizing the benefits of proper foot care.\n\nExperimental Group 2 (Loss-Framed): Participants receive loss-framed messages highlighting the risks of inadequate foot care.\n\nControl Group (Routine Messaging): Participants receive standard foot care messages without specific framing.\n\nParticipants:\n\nDiabetic patients recruited from Experimental Group 1, Experimental Group, and Control Group 3. Inclusion criteria include adults diagnosed with diabetes who are at risk for diabetic foot complications.\n\nIntervention:\n\nOver a period of three months, participants will receive WhatsApp messages three times a week.\n\nGain-Framed Messages: Emphasize positive outcomes, such as preventing foot ulcers by wearing appropriate footwear.\n\nLoss-Framed Messages: Highlight negative consequences, such as the increased risk of foot infections from improper foot care.\n\nMessages will include supportive images and videos to enhance engagement and understanding.\n\nOutcome Measures:\n\nPrimary Outcomes:\n\nFoot Care Behavior: Assessed using The Foot Care Behavior Scale. Self-Efficacy: Measured by the Diabetic Foot Care Self-Efficacy Scale Secondary Outcomes: Comparative effectiveness between gain-framed and loss-framed messages.Long-term behavioral changes post-intervention.\n\nSignificance:\n\nThis study seeks to determine the most effective messaging strategy to promote diabetic foot care, potentially informing future interventions to reduce the incidence of diabetic foot complications.', 'detailedDescription': 'Title: The Effect of Message Framing on Self-Efficacy and Foot Care Behaviors in Diabetic Foot Care: A Randomized Controlled Study\n\nAbstract:\n\nThis study aims to examine the effect of message framing on self-efficacy and foot care behaviors in diabetic foot care. Evaluating the impact of message framing on self-efficacy and foot care behaviors is crucial in reducing the economic burden of diabetic foot on healthcare services while simultaneously improving patients\' quality of life and daily functionality. The results of this study are expected to contribute to interventions aimed at enhancing self-efficacy in diabetic foot care and preventing diabetic foot complications.\n\nStudy Setting and Population:\n\nPatients will be recruited through diabetes-related social media groups. Eligible participants who agree to participate will be contacted via WhatsApp, where they will receive framed messages.\n\nStudy Design and Methodology:\n\nThis study is designed as a three-arm randomized controlled trial.\n\nPopulation and Sample: The study population consists of patients following diabetes-related social media groups. The sample will include individuals meeting the inclusion criteria and consenting to participate between May 15, 2024, and May 15, 2025. Participants will be randomly assigned to one of three groups: Experimental Group 1, Experimental Group 2, and Control Group 3. A three-month intervention will be implemented.\n\nSample Size Calculation: The sample size was determined using the G\\*Power 3.1.9.6 program. A three-group, two-measurement (pretest, posttest) design was considered. Based on an effect size of 0.50, a significance level of α = 0.05, and a power of 1-β = 0.80, the required sample size for each group was calculated as 49. Considering possible data loss, the sample size was increased by 10%, resulting in 54 participants per group and a total of 162 participants.\n\nRandomization: Simple random sampling (lottery method) will be used. The lottery draw will be conducted by an independent person with no contact with the participants.\n\nIntervention Procedure:\n\nParticipants in all groups will receive an online questionnaire via Google Forms, including a Patient Information Form, the Diabetic Foot Self-Efficacy Scale, and the Foot Care Behavior Scale.\n\nExperimental Group 1: Participants will receive gain-framed messages about diabetic foot care via a WhatsApp group. Three times a week for three months, they will be sent gain-framed messages and videos. For example, a message emphasizing proper footwear and socks will state: "Wearing appropriate shoes and socks that reduce foot friction helps prevent foot ulcers caused by vascular damage." Healthy foot images and videos will accompany the messages.\n\nExperimental Group 2: Participants will receive loss-framed messages via WhatsApp. Three times a week for three months, they will receive loss-framed messages and videos. An example message will be: "Wearing inappropriate shoes and socks that increase foot friction may lead to poor foot care and a higher risk of foot ulcers." Images of infected feet and videos of patients receiving treatment for diabetic foot complications will be shared.\n\nControl Group 3: Participants will receive neutral messages regarding foot care without specific message framing. For example, they will receive the message: "You should wear appropriate shoes and socks to prevent foot friction."\n\nAt the end of the intervention, the Diabetic Foot Self-Efficacy Scale and Foot Care Behavior Scale will be re-administered.\n\nData Collection Tools:\n\nPatient Information Form: Collects demographic data (age, gender, education level, date of diabetes diagnosis, presence of foot complications).\n\nDiabetic Foot Self-Efficacy Scale: Developed by Bonnie Elliott Quarles in 2005 to assess diabetic patients\' perceived ability to perform foot care activities. The Turkish validity and reliability study was conducted by Biçer and Enç in 2011. The 9-item scale is scored on a visual scale from 0 (not confident) to 10 (very confident), with a total score range of 0-90. A higher score indicates higher self-efficacy (Cronbach\'s α = 0.86).\n\nFoot Care Behavior Scale: Originally developed by Borges in 2007 as the Foot Care Observation Guide and later adapted by Biçer and Enç in 2011. This 15-item Likert-type scale measures foot care behaviors, ranging from 1 (never) to 5 (always). The total score ranges from 15 to 75, with higher scores indicating better foot care behaviors (Cronbach\'s α = 0.83).\n\nLimitations:\n\nThe study is limited to information measured by the surveys and to patients with internet access who voluntarily participate.\n\nEthical Considerations:\n\nEthical approval will be obtained from the Ethics Committee of Atatürk University Faculty of Medicine. Institutional permissions will be sought from relevant hospitals. Written informed consent will be obtained from participants.\n\nData Collection and Storage:\n\nData will be collected through Google Forms via WhatsApp after obtaining informed consent from voluntary participants.\n\nData Analysis:\n\nSurvey responses will be analyzed using SPSS software. Statistical analyses will include comparisons of pretest and posttest scores across groups using appropriate statistical methods.\n\nConclusion:\n\nThis study aims to evaluate the effectiveness of message framing on diabetic foot care self-efficacy and behaviors. Findings are expected to contribute to the development of targeted interventions that enhance diabetic foot care practices, reduce healthcare costs, and improve patients\' quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged between 18 and 55 years.\n* Individuals diagnosed with diabetes for at least six months.\n* Individuals without diabetic foot ulcers or amputations.\n* Individuals without any communication disorders or psychiatric illnesses.\n* Individuals who are members of a social media platform.\n* Individuals who can use a smartphone and have internet access.\n* Individuals willing to participate in the study.\n* Individuals with at least a primary school education.\n\nExclusion Criteria:\n\n* Individuals diagnosed with diabetes (This criterion seems unclear; please clarify if it should refer to a specific diabetes-related condition).\n* Individuals with diabetic foot ulcers or amputations.\n* Individuals with any communication disorders or psychiatric illnesses.\n* Individuals without access to a smartphone or the internet.\n* Individuals with malingering disorders.\n* Individuals who are illiterate.'}, 'identificationModule': {'nctId': 'NCT06813794', 'briefTitle': 'The Effect of Message Framing in Diabetic Foot Self-Management', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effect of Message Framing in Diabetic Foot Self-Management on Diabetic Foot Care Behaviors and Self-Efficacy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.0.01.00/327'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (Gain-Framed)', 'description': 'Participants receive gain-framed messages emphasizing the benefits of proper foot care.', 'interventionNames': ['Behavioral: Gain- Framed Messages']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will receive neutral messages about diabetic foot care.'}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (Loss-Framed)', 'description': 'Participants receive loss-framed messages highlighting the risks of inadequate foot care.', 'interventionNames': ['Behavioral: Lost Framed Messages']}], 'interventions': [{'name': 'Gain- Framed Messages', 'type': 'BEHAVIORAL', 'description': 'Patients will be recruited to whatsapp group based on gain framing about diabetic foot care skills. Gain framing messages and videos will be delivered to patients via whatsapp 3 times a week for 3 months.', 'armGroupLabels': ['Group 1 (Gain-Framed)']}, {'name': 'Lost Framed Messages', 'type': 'BEHAVIORAL', 'description': 'Patients will be included in whatsapp group based on Lost framing about diabetic foot care skills. Patients will receive loss framing messages and videos 3 times a week for 3 months via whatsapp.', 'armGroupLabels': ['Group 2 (Loss-Framed)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'state': 'Yakutiye', 'country': 'Turkey (Türkiye)', 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Mehtap Kavurmacı, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ataturk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Mehtap KAVURMACI', 'investigatorAffiliation': 'Ataturk University'}}}}