Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06700551
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2024-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mobile-Phone-Based Psychoeducation for Dementia Caregivers in Vietnam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Psychoeducation'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2024-10-20', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression, anxiety and stress levels', 'timeFrame': 'The evaluation period will span from enrollment to the end of the 7-week intervention and continue through three months post-intervention. Assessments will be conducted at three key time points: baseline (prior to the intervention), immediately after the', 'description': 'Levels of depression, anxiety, and stress will be assessed using the Depression, Anxiety, and Stress Scale (DASS-21), which includes three subscales. Each subscale has a scoring range from 0 to 42, resulting in a total possible score between 0 and 126. Higher scores indicate more severe symptoms and worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Demetia knowledge', 'timeFrame': 'The evaluation period will extend over 9 months. Assessments will be conducted at three time points: baseline (before the intervention), immediately post-intervention, and three months post-intervention.', 'description': "Participants' demntia knowledge will be assessed using a questionnaire adapted from the Northern Ireland Life and Times Survey, consisting of 7 items. The total score ranges from 0 to 7, with higher scores indicating better knowledge and understanding of dementia."}, {'measure': 'Caregiver burden', 'timeFrame': 'The evaluation period will extend over 9 months. Assessments will be conducted at three key time points: baseline (before the intervention), immediately post-intervention, and three months post- intervention.', 'description': 'Participants will be assessed using the Zarit 4-Item Burden Interview, which consists of four items. Each item is rated on a scale of 1 to 4, with higher scores indicating a greater sense of caregiver burden.'}, {'measure': 'Percieved social support', 'timeFrame': 'The evaluation will span 9 months, with assessments conducted at three key points: baseline (before the intervention), immediately post-intervention, and three months post-intervention.', 'description': 'Participants will be assessed using the Multidimensional Perceived Social Support Scale (MSPSS), which consists of 12 items. Each item is rated on a 7-point Likert scale, ranging from 1 (very strongly disagree) to 7 (very strongly agree). The total score ranges from 12 to 84, with higher scores indicating greater levels of perceived social support.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia', 'caregiver', 'depression', 'anxiety', 'stress', 'intervention', 'psychoeducation', 'mobile-phone'], 'conditions': ['Depression, Anxiety', 'Stress']}, 'referencesModule': {'references': [{'pmid': '18243894', 'type': 'RESULT', 'citation': 'Bruwer B, Emsley R, Kidd M, Lochner C, Seedat S. Psychometric properties of the Multidimensional Scale of Perceived Social Support in youth. Compr Psychiatry. 2008 Mar-Apr;49(2):195-201. doi: 10.1016/j.comppsych.2007.09.002. Epub 2007 Dec 21.'}, {'pmid': '22591515', 'type': 'RESULT', 'citation': 'McParland P, Devine P, Innes A, Gayle V. Dementia knowledge and attitudes of the general public in Northern Ireland: an analysis of national survey data. Int Psychogeriatr. 2012 Oct;24(10):1600-13. doi: 10.1017/S1041610212000658. Epub 2012 May 17.'}, {'pmid': '41158517', 'type': 'DERIVED', 'citation': 'Nguyen TTT, Vu LDT, Nguyen TC, Truong KT, Thai TT, Than THN, Nguyen HT. Mobile App Psychoeducation for Dementia Caregivers In Vietnam: A Randomized Controlled Trial. J Multidiscip Healthc. 2025 Oct 23;18:6871-6885. doi: 10.2147/JMDH.S557573. eCollection 2025.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/22591515/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/18243894/', 'label': 'https://pubmed.ncbi.nlm.nih.gov/18243894/'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/7726811/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/11574710/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to determine whether a mobile phone-based psychoeducational intervention can reduce stress among caregivers of individuals with dementia in Vietnam. The primary research question is: Does the intervention reduce levels of depression, anxiety, and stress among participants? The secondary research question is: Does the intervention increase caregivers' knowledge about dementia, enhance social support, or reduce caregiver burden?", 'detailedDescription': 'The study consists of two groups: an intervention group and a control group. Participants in the intervention group will receive psychoeducational content through the Zalo app on their mobile phones. Weekly, they will be provided with a topic related to dementia care, such as daily caregiving, fall prevention, pressure injury prevention and care, self-care, and coping as a caregiver. Levels of depression, anxiety, and stress will be assessed both before and after the intervention. In the control group, participants will continue receiving standard care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary Caregiver Requirement: Participants must have been the primary caregivers of poeple with dementia for at least the past 6 months and plan to continue in this role for the next 6 months of the intervention. Patients with demeentia criteria: Patients must have been diagnosed with dementia for at least 6 months and reside within the community.\n* Language and Education Requirement: Participants must be able to read and understand Vietnamese (with at least a primary education level) and be willing to participate in the study.\n* Smartphone Requirement: Participants must own a smartphone with the Zalo app or be willing to install it (with a brief training session provided for new users).\n* Age Requirement: Participants must be aged 18 years or older.\n\nExclusion Criteria:\n\n* Having any acute diseases or cognitive impairment (screening by Mini-Cog) or\n* Having vision or hearing impairment'}, 'identificationModule': {'nctId': 'NCT06700551', 'briefTitle': 'Mobile-Phone-Based Psychoeducation for Dementia Caregivers in Vietnam', 'organization': {'class': 'OTHER', 'fullName': 'University of Medicine and Pharmacy at Ho Chi Minh City'}, 'officialTitle': 'Evaluating the Efficacy of Mobile-Phone-Based Psychoeducation Intervention on Depression, Anxiety, and Stress in Dementia Caregivers', 'orgStudyIdInfo': {'id': '557-HDDD-DHYD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychoeducation Intervention Group', 'description': 'In the intervention group, participants will receive interventions through the Zalo app on their mobile phones. Weekly, the investigator will send a topic for participants to learn about. Participants will have the opportunity to ask questions and share their feelings or experiences through the Zalo app.', 'interventionNames': ['Other: Psychoeducation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants will receive usual care and will not receive any intervention'}], 'interventions': [{'name': 'Psychoeducation', 'type': 'OTHER', 'description': 'Each week, the investigator will send participants one topic through the chat function on the Zalo app. Before receiving the topic, participants will vote on which topic they would like to learn about. The topics will be presented as videos and will cover the following seven areas: providing everyday care, being a caregiver, self-care, knowledge about dementia, fall prevention, pressure injury prevention and care, and managing behavior changes.They may ask questions related to providing dementia care or share their feelings via the chat on the Zalo app.', 'armGroupLabels': ['Psychoeducation Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000', 'city': 'Ho Chi Minh City', 'state': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Nhan Dan Gia Dinh Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Tran TT Nguyen, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To ensure participant confidentiality, study results will only be shared upon the request and with the explicit agreement of the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nguyen Tran To Tran', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Medicine and Pharmacy at Ho Chi Minh City', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Nguyen Tran To Tran', 'investigatorAffiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City'}}}}