Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-01 @ 10:36 PM
Study NCT ID:
NCT05068869
Status:
UNKNOWN
Last Update Posted:
2023-12-01
First Post:
2021-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Outpatient Services
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2021-09-19', 'studyFirstSubmitQcDate': '2021-09-24', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Experiences with digital outpatient services', 'timeFrame': 'After 6 moths of study follow-up, the investigators will conduct the interviews', 'description': 'Qualitative interviews with patients and healthcare personnel will be conducted to assess their experiences with the new services.'}], 'primaryOutcomes': [{'measure': 'Change in Health literacy', 'timeFrame': 'Baseline, 3 months, and 6 months follow-up.', 'description': 'The HLQ is a standardized measure of health literacy, and the investigators will apply five of the nine domains; 1 Feeling understood and supported by healthcare providers; 2 Having sufficient information to manage my health; 3 Actively managing my health; 6 Ability to actively engage with healthcare providers; and 9 Understanding health information well enough to know what to do. the HLQ is is translated and validated in Norwegian.\n\n(Osborne et al. 2013; Wahl et al. 2020)'}], 'secondaryOutcomes': [{'measure': 'Change in Digital health literacy', 'timeFrame': 'Baseline, 3 months, and 6 months months follow-up.', 'description': 'The investigators will apply the eHLQ to measure level of digital health literacy. The eHLQ contains 35 items summarized in seven domains: 1) using technology to process health information, 2) understanding of health concepts and language, 3) ability to actively engage with digital services, 4) feel safe and in control, 5) motivated to engage with digital services, 6) access to digital services that work, and 7) digital services that suit individual needs. Higher scores indicate better digital health literacy. Domains 1-5 consist of 5 items, domain 6 consists of 6 items, and domain 7 consists of 4 items.\n\n(Kayser et al. 2018)'}, {'measure': 'Change in Health/ quality of life', 'timeFrame': 'Baseline, 3 months, and 6 months follow-up.', 'description': 'To assess the patient reported health or quality of life the investigators will use the 12-Item Short Form Survey from the RAND Medical Outcomes Study (RAND-12) (Ware et al. 1996). The items summarizes into two scales; mental component score and Physical component score. Higher scores indicate better health, and the instruments is translated and validated in Norwegian.'}, {'measure': 'Change in Perceived safety in a pandemic', 'timeFrame': 'Baseline, 3 months, and 6 months follow-up.', 'description': 'To assess the participants self-perceived safety in the pandemic the investigators will apply the item: "How anxious are you to be infected with Covid-19 (corona)?" with responses on a 5 point Likert scale from "Not anxious" to "Very anxious" .'}, {'measure': 'Change in Satisfaction with digital services', 'timeFrame': '3 months, and 6 months follow-up.', 'description': 'The Service User Technology Acceptability Questionnaire (SUTAQ) is an instrument that can be used to measure user beliefs about the acceptability of digital services, and has the ability to discriminate and predict individual differences in beliefs and behaviour.\n\n(Hirani et al 2016; Torbjørnsen et al. 2018)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital outpatient services', 'Health literacy', 'mHealth', 'eHealth', 'Satisfaction', 'Controlled trial'], 'conditions': ['Epilepsy', 'Cancer', 'Interstitial Lung Disease', 'Long Term Pain']}, 'referencesModule': {'references': [{'pmid': '40294411', 'type': 'DERIVED', 'citation': 'Holmen H, Holm AM, Falk RS, Kilvaer TK, Ljosaa TM, Ekholdt C, Fosse E. A Digital Outpatient Service With a Mobile App for Tailored Care and Health Literacy in Adults With Long-Term Health Service Needs: Multicenter Nonrandomized Controlled Trial. J Med Internet Res. 2025 Apr 28;27:e60343. doi: 10.2196/60343.'}, {'pmid': '37428533', 'type': 'DERIVED', 'citation': 'Holmen H, Holm AM, Kilvaer TK, Ljosa TM, Granan LP, Ekholdt C, Larsen LS, Fosse E. Digital Outpatient Services for Adults: Development of an Intervention and Protocol for a Multicenter Non-Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 10;12:e46649. doi: 10.2196/46649.'}]}, 'descriptionModule': {'briefSummary': "More people are living with chronic or long-term disorders together and they live longer, which gives an increase in patients who need health services. Seen in the context of the shorter lengths of stay, and the outpatient clinics' increasing responsibility, there is a need to increase outpatient capacity without leading to more patient readmissions. Further, new services should take into account the patients capacity to benefit from the services, and their level of health literacy is crucial. By developing new services using technology, patients will be able to be followed up closely in their own home with adapted treatment and information, a closer dialogue with the health service where there is a need, and the utilization of scarce resources in the health care system can increase.\n\nThe aim of the current study is to evaluate a digital outpatient clinic, and assess any differences over time in health literacy, digital health literacy, quality of life and overall satisfaction with the outpatient services. Furthermore, the investigators will assess the intervention group's satisfaction with the digital outpatient clinic. In addition, the digital services will be tailored and revised throughout the study based on continuous feedback and iterative processes.\n\nThe current study is a pragmatic controlled multicenter study with two study arms; one control arm and one intervention arm. In total, eligible participants will be recruited from one of four centers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients attending the study centers that are cognitively able to use a digital outpatient service with no major conflicting disorders, with one of the following disorders:\n* cancer\n* epilepsy\n* interstitial lung disease\n* long-term complex pain conditions\n\nExclusion Criteria:\n\n* under the age of 18\n* any mental or cognitive conditions interfering with their ability to participate'}, 'identificationModule': {'nctId': 'NCT05068869', 'briefTitle': 'Digital Outpatient Services', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Digital Outpatient Services - a Controlled Multicenter Study', 'orgStudyIdInfo': {'id': '21/06826'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dignio Digital Remote Care intervention group', 'description': 'Participants will receive the MyDignio app for individualized follow-up for 6 months.', 'interventionNames': ['Other: Dignio Digital Remote Care intervention group']}, {'type': 'OTHER', 'label': 'Usual Care Control group', 'description': 'Participants in the control group will receive follow-up at the outpatient clinic as per their needs.', 'interventionNames': ['Other: Usual Care Control group']}], 'interventions': [{'name': 'Dignio Digital Remote Care intervention group', 'type': 'OTHER', 'description': 'The intervention consists of Dignio Prevent (for healthcare professionals) and MyDignio (for patients). The system is CE marked and the system satisfies all regulatory requirements for privacy and information security. Various components can be added for an individualized follow-up of the patients.\n\nElements of the digital outpatient service in Dignio include patient reported outcomes and other questionnaires, tasks, objective measures, reminders and information, in addition to a chat function for asynchronous contact with healthcare personnel and video consultations for real-time consultations.', 'armGroupLabels': ['Dignio Digital Remote Care intervention group']}, {'name': 'Usual Care Control group', 'type': 'OTHER', 'description': 'Participants in the control group will receive follow-up at the outpatient clinic as per their needs.', 'armGroupLabels': ['Usual Care Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Tromsø', 'country': 'Norway', 'facility': 'University Hospital of North Norway', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}], 'overallOfficials': [{'name': 'Erik Fosse, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oslo University Hospital'}, {'name': 'Heidi Holmen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of North Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post doctor', 'investigatorFullName': 'Heidi Holmen', 'investigatorAffiliation': 'Oslo University Hospital'}}}}