Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-29 @ 5:14 PM
Study NCT ID:
NCT06176495
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empowering Patients With Diabetes and Their Family Members: Assessing the Impact of Free Informative Mobile Messages
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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2023-12-09', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in glycemic control determined by HbA1C (in percent) in participants with diabetes pre and post intervention.', 'timeFrame': 'at 3 and 6 months interval', 'description': 'To determine the effectiveness of diabetes tailored text messages on glycemic control in patients with diabetes mellitus, Percentage change in glycemic control determined by HbA1C (in percent) in participants with diabetes pre and post intervention will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Change in knowledge before and after the intervention (in percentage)', 'timeFrame': 'at 3 and 6 months interval', 'description': "Assessment of the change in percentage of knowledge in both the patients' and family members' that will be assessed based on the questionnaire that is to be filled before and after the intervention.\n\nChi-squared test will be utilised with a p-value of ≤ 0.05 being considered as statistically significant."}, {'measure': 'Changes in Daily Health Practices pre and post intervention (in percentage)', 'timeFrame': 'at 3 and 6 months interval', 'description': 'the participants daily health practices will be assessed using a designed questionnaire. the changes in health practices will be assessed pre and post intervention using delta percentage.\n\nChi-squared test will be utilised with a p-value of ≤ 0.05 being considered as statistically significant.'}, {'measure': 'Percentage change in weight (in Kg), height (in meters) and BMI (Kg/m2) pre and post intervention', 'timeFrame': 'At 3 and 6 months interval', 'description': 'Percentage change in weight (in kg), height ( in meters) and BMI (in Kg/m2) pre and post intervention in participants with diabetes'}, {'measure': 'Percentage change in fasting sugar (mg/dl) pre and post intervention among participants with diabetes', 'timeFrame': 'At 3 and 6 months interval', 'description': 'Percentage change in fasting sugar (mg/dl) pre and post intervention among participants with diabetes'}, {'measure': 'Percentage change in lipid profile composed of Total Cholesterol, LDL, HDL and Triglycerides ( all in mg/dl) among participants with diabetes pre and post intervention', 'timeFrame': 'At 3 and 6 months interval', 'description': 'Percentage change in lipid profile composed of Total Cholesterol, LDL, HDL and Triglycerides ( all in mg/dl) among participants with diabetes pre and post intervention'}, {'measure': 'Percentage change in systolic and diastolic blood pressure (in mmHg) in participants with diabetes pre and post intervention', 'timeFrame': 'At 3 and 6 months interval', 'description': 'Percentage change in systolic and diastolic blood pressure (in mmHg) in participants with diabetes pre and post intervention'}, {'measure': 'Assessment of Changes in Depression Screening score (in percentage pre and post intervention)', 'timeFrame': 'At 3 and 6 months interval', 'description': "Changes in patients' depression screening score pre and post intervention using the PHQ 2 scaled score. This will be reflected in percentage (pre and post intervention) to reflect the changes in the participants' mood. Chi-squared test will be utilised with a p-value of ≤ 0.05 being considered as statistically significant.\n\nFor the PHQ-2, the score ranges from 0-6. A score of 3 is considered as the optimal cut point when using the PHQ-2 to screen for depression. If the score is 3 or greater, major depressive disorder is likely."}, {'measure': 'Assessment of Changes in Anxiety Screening score (in percentage pre and post intervention)', 'timeFrame': 'At 3 and 6 months interval', 'description': "Changes in patients' anxiety screening score pre and post intervention using the GAD 2 scaled score. This will be reflected in percentage (pre and post intervention) to reflect the changes in the participants' mood. Chi-squared test will be utilised with a p-value of ≤ 0.05 being considered as statistically significant.\n\nFor the GAD-2, the score ranges from 0-6. A score of 3 is considered as the optimal cut point when using the GAD-2 to screen for generalised anxiety. If the score is 3 or greater, generalised anxiety is likely."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Family Member Caregivers', 'Education', 'Educational text messages', 'WhatsApp'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '35172997', 'type': 'BACKGROUND', 'citation': 'Al-Mutawaa KA, Farghaly AH, Nasir R, Loares AM, Skaroni I, Al-Thani M, Abou-Samra AB. Level of knowledge, attitude and practice towards diabetes among nationals and long-term residents of Qatar: a cross-sectional study. BMJ Open. 2022 Feb 16;12(2):e052607. doi: 10.1136/bmjopen-2021-052607.'}, {'pmid': '29258499', 'type': 'RESULT', 'citation': 'Abaza H, Marschollek M. SMS education for the promotion of diabetes self-management in low & middle income countries: a pilot randomized controlled trial in Egypt. BMC Public Health. 2017 Dec 19;17(1):962. doi: 10.1186/s12889-017-4973-5.'}, {'pmid': '33855427', 'type': 'RESULT', 'citation': 'Ernawati U, Wihastuti TA, Utami YW. Effectiveness of diabetes self-management education (DSME) in type 2 diabetes mellitus (T2DM) patients: Systematic literature review. J Public Health Res. 2021 Apr 14;10(2):2240. doi: 10.4081/jphr.2021.2240.'}, {'pmid': '29678148', 'type': 'RESULT', 'citation': 'Karaoui LR, Deeb ME, Nasser L, Hallit S. Knowledge and practice of patients with diabetes mellitus in Lebanon: a cross-sectional study. BMC Public Health. 2018 Apr 20;18(1):525. doi: 10.1186/s12889-018-5416-7.'}, {'pmid': '31041110', 'type': 'RESULT', 'citation': 'Sahin C, Courtney KL, Naylor PJ, E Rhodes R. Tailored mobile text messaging interventions targeting type 2 diabetes self-management: A systematic review and a meta-analysis. Digit Health. 2019 Apr 22;5:2055207619845279. doi: 10.1177/2055207619845279. eCollection 2019 Jan-Dec.'}, {'pmid': '25745493', 'type': 'RESULT', 'citation': 'Bin Abbas B, Al Fares A, Jabbari M, El Dali A, Al Orifi F. Effect of mobile phone short text messages on glycemic control in type 2 diabetes. Int J Endocrinol Metab. 2015 Jan 1;13(1):e18791. doi: 10.5812/ijem.18791. eCollection 2015 Jan.'}, {'pmid': '32477434', 'type': 'RESULT', 'citation': 'Omar MA, Hasan S, Palaian S, Mahameed S. The impact of a self-management educational program coordinated through WhatsApp on diabetes control. Pharm Pract (Granada). 2020 Apr-Jun;18(2):1841. doi: 10.18549/PharmPract.2020.2.1841. Epub 2020 May 3.'}], 'seeAlsoLinks': [{'url': 'https://idf.org/about-diabetes/facts-figures/', 'label': 'statistical figures'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/32141596/', 'label': 'statistical figures'}, {'url': 'https://apps.who.int/gho/data/view.main.NCDRGLUCAv?lang=en%5D', 'label': 'statistical figures'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5735794/', 'label': 'SMS education for the promotion of diabetes self-management in low \\& middle income countries: a pilot randomized controlled trial in Egypt'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8129774/', 'label': 'Effectiveness of diabetes self-management education (DSME) in type 2 diabetes mellitus (T2DM) patients: Systematic literature review'}, {'url': 'https://www.scielo.br/j/aem/a/VCBKnRL6km3qjGsf3LbFDFg/?lang=en', 'label': 'Educating diabetic patients through an SMS intervention: a randomized controlled trial at a Brazilian public hospital'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/29678148/', 'label': 'Knowledge and practice of patients with diabetes mellitus in Lebanon: a cross-sectional study'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/35172997/', 'label': 'Level of knowledge, attitude and practice towards diabetes among nationals and long-term residents of Qatar: a cross-sectional study (With KAP Questionnaire)'}, {'url': 'https://jech.bmj.com/content/68/6/557.long', 'label': 'Disease-related distress, self-care and clinical outcomes among low-income patients with diabetes'}, {'url': 'https://www.intechopen.com/chapters/75367', 'label': 'Family-Centered Diabetes Care for Better Glycemic Outcomes of Outpatients in Rural Areas'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6481002/', 'label': 'Tailored mobile text messaging interventions targeting type 2 diabetes self-management: A systematic review and a meta-analysis'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4338653/', 'label': 'Effect of Mobile Phone Short Text Messages on Glycemic Control in Type 2 Diabetes'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7243744/', 'label': 'The impact of a self-management educational program coordinated through WhatsApp on diabetes control'}]}, 'descriptionModule': {'briefSummary': "This is a Randomized Control Trial aiming at investigating the feasibility and effectiveness of a WhatsApp-based informative intervention on Diabetes Mellitus care in Lebanon and exploring the impact of this intervention on various aspects of Diabetes management and patient outcomes.\n\nFamily member caregivers will be also included in this interventional study as the research investigators opt to evaluate their DM related knowledge, personal health practices, their involvement in the care of patients with diabetes, and their impact on the patients' diabetes control before and after the intervention.", 'detailedDescription': "Participants with diabetes will be equally and randomly divided into an intervention group (patients with diabetes and their designated family member) of individualized WhatsApp groups which will include each participant individually and the study coordinator to protect their privacy; regular, 4-5 diabetes educational messages a week for a total of 12 weeks will be sent by noon (around 12 pm) to the intervention group participants. The other group, control group, will receive no text messages throughout this period. After 3 months, participants of the intervention group (patients with diabetes and their family members) will be asked to fill in a postintervention knowledge and practices questionnaire to delineate any marked differences in the context of knowledge and health behaviors. All participants with diabetes of both groups will be asked to recheck the previously noted clinical and laboratory parameters at 12 weeks to evaluate for any changes particularly among the intervention group who will also be asked to fill out a postintervention survey. After 6 months, all patients with diabetes will be asked to recheck their clinical and laboratory values again and members of the intervention group will be asked to fill in the practices section questionnaire again.\n\nThis research will additionally include Family Members of patients with diabetes who are involved in their care (cooking, aiding in management, securing/delivering medications, etc.). Family Member Caregivers of participants will be designated/noted by the participants who have diabetes themselves, and they will be included in the study based on their willingness to take part of the study. They will also be sorted into either a control or an intervention group in accordance with which group their relative with diabetes was sorted into, for example, if the patient with diabetes will be designated to be a part of the intervention group, this means that the family member caregiver participant will also be allocated to the intervention group. Our aim is to evaluate their DM related knowledge, personal health practices, their involvement in the care of patients with diabetes, and their impact on the patients' diabetes control before and after the intervention.\n\nOne point to note as well is that to ensure equality among groups and for the benefit of the control group participants, the research investigators will be sharing with them the content of the text messages originally shared with the participants of the intervention group by the End of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria for Participants with Diabetes:\n\n* Adult patients 18 years or older\n* Patients with an established DM diagnosis\n* Patients with a recent HbA1c level with no recent changes in treatment regimen\n* Recent HbA1c \\> 7 but less than 9\n* Patients who are on oral antidiabetic medications or basal insulin (intermediate, long acting, ultra long acting insulin)\n* Patients who are adherents to the American University of Beirut Health Insurance Plan (AUB-HIP)\n* Patients who have visited the Family Medicine Primary Care Clinics at American University of Beirut Clinics in the past 12 months.\n* Patients with smart mobile phones and/or access to WhatsApp services\n* Patients who can speak and read Arabic or English or live with someone who can read for them\n* Patients with available family members involved in their care (e.g. cooking, aiding in management, securing/delivering medications, having the patient medically insured, etc.).\n* Willingness to participate in the study\n\nExclusion Criteria for participants with Diabetes:\n\n* Young patients below 18 years\n* Patients who are on non basal insulin/bolus therapy\n* Adults with cognitive impairment\n* Adults with functional dependence and no assisting family member or caregiver\n* Pregnant and Postpartum patients\n* Patients with terminal or critical diseases (e.g., cancer; advanced heart, lung, liver, and kidney disease; Human immunodeficiency virus infection and Acquired immune deficiency syndrome and etc.)\n* Patients with severe hearing or visual impairment\n* Patients who can't read or have difficulty reading and do not live with someone who can read for them\n* Patients who will have any of their medications modified throughout the study process will be excluded from the study as well\n* Patients with a positive depression (PHQ 2) and/or anxiety (GAD 2) screening results who will be asked to follow up with their primary physician\n\nInclusion Criteria for Family Member Caregivers:\n\n* Age 18 years or older\n* Designated or selected by the participating patient with diabetes.\n* Not diagnosed with DM\n* Can read and write\n* No visual or hearing impairments\n* Involved in the participant's diabetes or general care and has an influence on the participant's lifestyle behaviors or medical insurance (e.g. cooking, aiding in management, securing/delivering medications, having the patient medically insured, etc.).\n* Access to the WhatsApp service\n* Willingness to participate in the study"}, 'identificationModule': {'nctId': 'NCT06176495', 'briefTitle': 'Empowering Patients With Diabetes and Their Family Members: Assessing the Impact of Free Informative Mobile Messages', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Empowering Patients With Diabetes and Their Family Members: Assessing the Impact of Free Informative Mobile Messages', 'orgStudyIdInfo': {'id': 'SBS-2023-0225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients with Diabetes and Family Member Caregivers who will receive no text messages over the designated period of the designated'}, {'type': 'OTHER', 'label': 'Intervention Group', 'description': 'Patients with Diabetes and Family Member Caregivers who will receive Educational Text Messages via WhatsApp over the designated period of the intervention', 'interventionNames': ['Diagnostic Test: Educational Text Messages']}], 'interventions': [{'name': 'Educational Text Messages', 'type': 'DIAGNOSTIC_TEST', 'description': 'The educational content will be targeted about Diabetes Education and will be guideline based with what complies to the standards of care instituted by the American Diabetes Association.\n\nThey text messages will comprise content related to general diabetes knowledge, diabetes management and control, coping with diabetes, and guidance on adopting a healthy lifestyle.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Najla El Lakkis, FAM MED', 'role': 'CONTACT', 'email': 'ne23@aub.edu.lb', 'phone': '01-350000', 'phoneExt': '3020'}, {'name': 'Farah Farhat, MD', 'role': 'CONTACT', 'email': 'ff38@aub.ed.lb', 'phone': '01-350000', 'phoneExt': '3020'}], 'overallOfficials': [{'name': 'Najla El Lakkis, FAM MED', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Family Medicine; Specialist in Occupational Medicine; Clinical Associate in Family Medicine', 'investigatorFullName': 'Najla El Lakkis', 'investigatorAffiliation': 'American University of Beirut Medical Center'}}}}