Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:27 AM
Study NCT ID:
NCT07423351
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedicine-Based Behavioral Intervention to Improve Outcomes Among Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetic management outcome', 'timeFrame': 'The intervention will be delivered over a period of three months, with participants in the intervention group receiving 15-30 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.', 'description': 'Glycemic control will be assessed using glycated hemoglobin (HbA1c), which reflects average blood glucose levels over the preceding 2-3 months. HbA1c will be measured through standardized laboratory testing using venous blood samples collected at baseline and at the end of the three-month intervention period.\n\nSamples will be analyzed in accredited hospital laboratories using standardized assay methods. Glycemic control will be evaluated by comparing HbA1c levels before and after the intervention. A reduction in HbA1c indicates improved glycemic control. Participants achieving an HbA1c level of \\<7% will be classified as having good glycemic control, in accordance with standard clinical guidelines.'}], 'secondaryOutcomes': [{'measure': 'Medication Adherence', 'timeFrame': 'The intervention will be delivered over a period of three months, with participants in the intervention group receiving 15-30 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.', 'description': 'Medication adherence will be measured using the Hill-Bone Medication Adherence Scale adapted for diabetes management, which assesses behaviors related to taking prescribed antidiabetic medications. The scale evaluates the frequency of missed doses, timing adherence, and correct dosing over the past seven days.\n\nScores will be calculated according to standardized Hill-Bone criteria, with higher scores indicating better adherence. Medication adherence will be classified as good if all prescribed doses are taken on all seven days, and poor if any dose is missed.'}, {'measure': 'Hospital Admission', 'timeFrame': 'baseline and three months', 'description': 'Hospital admission due to diabetes-related complications will be assessed using a self-report question: "Have you been admitted to a hospital in the past one month due to diabetes or its complications?" Responses will be coded as 1 = Yes and 2 = No. This outcome will be analyzed as a binary variable, with "Yes" indicating an admission and "No" indicating no admission.\n\nThe measure will be collected at baseline and at the end of the intervention period to evaluate recent hospitalization related to diabetes.'}, {'measure': 'Diabetes Self-Care Practice', 'timeFrame': 'The intervention will be delivered over a period of three months, with participants in the intervention group receiving 15-30 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.', 'description': 'Diabetes self-care practice will be measured using the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire, a validated instrument that assesses adherence to key diabetes self-management behaviors. The SDSCA evaluates the frequency of self-care activities performed over the past seven days across multiple domains, including general diet, specific diet, physical activity, blood glucose testing, foot care, and medication adherence.\n\nEach item is scored based on the number of days (0-7) the activity was performed during the previous week. Domain scores will be calculated according to standardized SDSCA guidelines, and higher scores indicate better self-care practice. Overall self-care practice will be classified as good if participants achieve at least 70% of the recommended behaviors across domains, and poor if they score below this threshold.'}, {'measure': 'Diabetes Knowledge Score', 'timeFrame': 'The intervention will be delivered over a period of three months, with participants in the intervention group receiving 15-30 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.', 'description': "Diabetes knowledge will be measured using the Diabetes Knowledge Questionnaire (DKQ-24), a validated instrument designed to assess patients' understanding of diabetes and its management. The questionnaire consists of 24 items covering key areas, including disease etiology, symptoms, treatment, medication use, diet, physical activity, blood glucose monitoring, and prevention of complications.\n\nEach item is scored as correct or incorrect according to standardized DKQ-24 scoring guidelines. The total knowledge score ranges from 0 to 24, with higher scores indicating better diabetes-related knowledge. Participants scoring ≥70% of correct responses will be classified as having good diabetes knowledge, while those scoring below this threshold will be classified as having poor knowledge."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Behavioral intervention', 'Diabetes Mellitus', 'Telemedicine', 'Quasi-experimental study'], 'conditions': ['Diabete Mellitus', 'Diabetes Knowledge Score']}, 'descriptionModule': {'briefSummary': "The goal of this quasi-experimental clinical study is to learn whether a telemedicine-based behavioral intervention can improve health outcomes among adult patients with diabetes receiving care at tertiary hospitals in Northwest Amhara, Ethiopia.\n\nThe main questions it aims to answer are:\n\n* Does a telemedicine-based behavioral intervention improve glycemic control (HbA1c) among diabetic patients?\n* Does the intervention improve medication adherence among diabetic patients?\n* Does the intervention improve diabetes self-care practices?\n* Does the intervention increase patients' knowledge about diabetes?\n* Does the intervention reduce hospital admissions among diabetic patients?\n\nWe will compare patients who receive telemedicine-based counseling with patients who receive usual care to see if the intervention improves glycemic control, medication adherence, self-care practices, diabetes knowledge, and reduces hospital admissions.\n\nParticipants will:\n\n* Receive structured telephone-based education every two weeks for three months (intervention group only)\n* Participate in 30-50-minute counseling sessions during the first call and 15-30 Minutes sessions during subsequent calls (intervention group only)\n* Receive education on diabetes basics, nutrition and meal planning, physical activity, medication management, blood glucose monitoring, complication prevention, and psychosocial support (intervention group only)\n* Engage in interactive discussions and receive individualized guidance from trained nurses (intervention group only)\n* Continue routine diabetes care at the hospital (both groups)", 'detailedDescription': 'Diabetes mellitus (DM) is one of the fastest-growing non-communicable diseases in Ethiopia, contributing significantly to premature morbidity, mortality, and healthcare costs. Despite national efforts to improve chronic disease management, diabetic patients in Ethiopia continue to experience suboptimal glycemic control, high rates of complications, inconsistent follow-up, and limited access to specialist care. Traditional face-to-face service delivery in tertiary hospitals is often constrained by long travel distances, overcrowded clinics, inadequate consultation time, and shortages of trained providers. All of these challenges hinder effective self-management support and timely monitoring.\n\nTelemedicine has emerged globally as a promising strategy to bridge gaps in chronic disease management by enhancing continuity of care, enabling remote monitoring, improving patient engagement, and reducing unnecessary hospital visits. Evidence from various low- and middle-income countries shows that telemedicine-based diabetes care can improve glycemic outcomes, diabetes self-management behaviors (medication adherence, dietary adherence, and physical activity adherence), and patient satisfaction. However, in Ethiopia, the integration of telemedicine into routine chronic care is still in its infancy, and there is limited evidence on feasibility, fidelity, and effectiveness in resource-constrained tertiary hospital settings.\n\nTertiary hospitals in the Northwest Amhara region serve large catchment populations, where physical access is uneven and many patients face geographic, financial, and time-related barriers that hinder regular follow-up. At the same time, mobile phone ownership and digital literacy are rapidly improving, creating a favorable environment for telemedicine-supported diabetes care. There is a need for locally tailored, evidence-based telemedicine intervention guidelines that can standardize remote consultations, patient education, medication review, monitoring of clinical indicators, and follow-up protocols.\n\nThis intervention guideline tool was developed to support the implementation and fidelity monitoring of a structured telemedicine-based diabetes care model within the context of a quasi-experimental study. The guideline outlines standardized procedures for virtual consultations, patient assessment, documentation, and follow-up, ensuring consistent delivery of the intervention across participating tertiary hospitals. The guideline also provides a structured framework for evaluating fidelity, quality, and patient outcomes, enabling the investigators to determine whether the telemedicine intervention leads to measurable improvements in clinical, behavioral, and service-related outcomes.\n\nOverall, the rationale for developing this guideline tool is to ensure high-quality, consistent, and replicable telemedicine implementation, strengthen evidence on digital health interventions for chronic care in Ethiopia, and generate context-specific insights that can inform national policy, scale-up decisions, and future digital health strategies.\n\nA two-arm quasi-experimental study design with parallel groups and a 1:1 allocation ratio will be employed to evaluate the effect of telemedicine-based education on outcomes among patients with diabetes mellitus. The study setting will include two teaching hospitals in Northwest Amhara: the University of Gondar Comprehensive Specialized Hospital and Tibebe Ghion Comprehensive Specialized Hospital. The intervention group will receive telemedicine-based diabetes care in addition to standard care, while the control group will receive standard routine hospital follow-up only. The follow-up duration will be three months, and data will be collected at baseline and at three months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients ≥18 with diabetes mellitus who have follow-up for ≥6 months at the study settings\n* Have access to mobile or fixed telephones\n* Will stay for the study follow-up period\n\nExclusion Criteria:\n\n* Participants who have coexisting severe mental health illnesses\n* Severe hearing impairments\n* Pregnant will be excluded\n* Currently enrolled in another diabetes intervention study'}, 'identificationModule': {'nctId': 'NCT07423351', 'briefTitle': 'Telemedicine-Based Behavioral Intervention to Improve Outcomes Among Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bahir Dar University'}, 'officialTitle': 'The Effects of the Telemedicine-Based Behavioral Intervention on Improving the Outcomes of Diabetic Patients in Northwest Amhara Tertiary Hospitals, Ethiopia, 2025/26: A Quasi-Experimental Study Intervention Protocol', 'orgStudyIdInfo': {'id': '6007/2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Telemedicine-Based Behavioral Intervention Arm', 'description': 'The intervention arm will receive a telemedicine-based behavioral intervention, including structured telephone counseling sessions every two weeks for three months. The first session will last 30-50 minutes, followed by 10-15-minute sessions for subsequent calls.\n\nTrained nurses will provide education on diabetes basics, blood glucose monitoring, medication adherence, nutrition and meal planning, physical activity, prevention and management of complications, and psychosocial support. Interactive discussions and individualized guidance will be incorporated into each session.\n\nThe intervention package is designed based on existing literature and culturally appropriate practices. Participants in this arm will receive regular follow-up and tailored self-care support in addition to routine hospital care.', 'interventionNames': ['Behavioral: Telemedicine-Based Diabetes Self-Management Counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care Control Arm', 'description': 'The control arm will receive standard diabetes care provided at the tertiary hospitals. This may include routine outpatient follow-up visits, prescribed medications, laboratory monitoring, and general health education as part of routine clinical practice.\n\nParticipants in this arm will not receive the telemedicine-based counseling, structured follow-up, or individualized self-care support provided to the intervention group.'}], 'interventions': [{'name': 'Telemedicine-Based Diabetes Self-Management Counseling', 'type': 'BEHAVIORAL', 'description': 'Participants in the intervention group will receive telephone-based behavioral counseling focused on diabetes self-management. Counseling sessions will be conducted every two weeks for three months by trained healthcare providers.\n\nThe intervention will emphasize glycemic control, adherence to prescribed medications, healthy dietary practices, regular physical activity, self-monitoring of blood glucose, recognition of warning signs, and stress management. The program aims to empower patients to actively participate in managing their condition and improving clinical outcomes.', 'armGroupLabels': ['Telemedicine-Based Behavioral Intervention Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Eyob K Bogale, Master of Public Health', 'role': 'CONTACT', 'email': 'ketema.eyob@gmail.com', 'phone': '+251961640637'}, {'name': 'Asnake G Belayneh, Master in Emergency Nursing', 'role': 'CONTACT', 'email': 'asnakegashaw27@gmail.com', 'phone': '0918793885'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared due to confidentiality and privacy concerns, as the dataset contains sensitive health information. Sharing is restricted by ethical approvals and participant consent limitations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bahir Dar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eyob Ketema Bogale', 'investigatorAffiliation': 'Bahir Dar University'}}}}