Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT03628469
Status:
COMPLETED
Last Update Posted:
2020-02-06
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proactive Health Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial with 1:1 randomization stratified for risk of hospital admission and region'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5454}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital admissions', 'timeFrame': '6 months'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'Questionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal)'}], 'secondaryOutcomes': [{'measure': 'Patient education', 'timeFrame': '3, 6 and 12 months', 'description': 'Questionnaire Hei-Q - all 8 subscales (health-directed activities, positive and active engagement in life, emotional distress, self-monitoring and insight, constructive attitudes and approaches, skill and technique acquisition, social integration and support, health service navigation, range 1-4)'}, {'measure': 'Outpatient consultations', 'timeFrame': '3, 6 and 12 months'}, {'measure': 'Use of primary healthcare', 'timeFrame': '3, 6 and 12 months'}, {'measure': 'Use of prescription medication', 'timeFrame': '3, 6 and 12 months'}, {'measure': 'Survival', 'timeFrame': '1 year'}, {'measure': 'Quality of life', 'timeFrame': '3, 6 and 12 months', 'description': 'Questionnaire SF36: All eight subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health and health transition, range 0-100. Furthermore, norm-based T-scores are reported, 45-55 is considered normal) and two composite scores (mental and physical health, norm-based T-score of 45-55 is considered normal)'}, {'measure': 'Incremental cost effectiveness ratio by comparison of costs with quality adjusted life years', 'timeFrame': '3, 6 and 12 months'}, {'measure': 'Regional differences in resource use and costs', 'timeFrame': '3, 6 and 12 months'}, {'measure': 'Resource use in primary care and rehabilitation', 'timeFrame': '3, 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients at Risk of Hospital Admission']}, 'referencesModule': {'references': [{'pmid': '32320846', 'type': 'DERIVED', 'citation': 'Benthien KS, Rasmussen K, Nielsen CP, Hjarnaa L, Rasmussen MK, Kidholm K, Nielsen BK, Nissen NK, Fredens M, Winther S, Gronkjaer M, Toft U. Proactive health support (PaHS) - telephone-based self-management support for persons at risk of hospital admission: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2020 Jun;93:106004. doi: 10.1016/j.cct.2020.106004. Epub 2020 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'Proactive Health Support is a randomized controlled trial of telephone-based self-management support. The primary aim of the intervention is to reduce hospital admissions and improve quality of life in patients with a high risk of hospital admission.', 'detailedDescription': 'Participants are identified through an algorithm, that assigns each patient with a risk score of 0-100%. Patients with the highest risk in each of the five regions of Denmark are invited to participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons with a hospital contact within the last year caused by ≥ 1 of the following diagnoses: heart diseases (DI110, DI130, DI132, DI50), connective tissue diseases (DD86, DM05, DM06, DM08, DM09, DM30, DM31, DM32, DM33, DM34, DM35, DM36), pulmonary diseases (DJ40, DJ41, DJ42, DJ43, DJ44, DJ45, DJ46, DJ47, DJ60, DJ61, , DJ62, DJ63, DJ64, DJ65, DJ66, DJ67, DJ684, DJ701, DJ703, DJ841, DJ842, DJ843, DJ848, DJ849, DJ920, DJ961, DJ982, DJ983) or diabetes (DE10, DE11, DE14) Or\n* Persons ≥ 18 years and ≥ three unplanned hospital admissions in the last six months Or\n* Persons ≥ 65 years with a preventable hospital admission (predefined diagnoses: dehydration, constipation, lower respiratory tract infections, urinary tract infections, gastroenteritis, fractures, nutrition deficiency anemia, social causes and pressure ulcers) or a readmission (within 30 days)\n\nExclusion Criteria:\n\n* Selected psychiatric diagnoses: substance abuse disorder (DF1), schizophrenia (DF2) or dementia (DF00, DF01, DF02, DF03, DF051)\n* Metastatic cancer (DC77, DC78, DC79, DC80)\n* Assisted living Facility\n* Documented terminal illness or life expectancy \\< one year\n* Assessment of dementia\n* Major surgery planned within 6 months\n* Hearing impairment\n* Not speaking Danish\n* Cognitive impairment\n* Substance abuse, that impairs adherence\n* No telephone\n* Receiving similar trial intervention\n* Other (including intervention not suitable)'}, 'identificationModule': {'nctId': 'NCT03628469', 'briefTitle': 'Proactive Health Support', 'organization': {'class': 'OTHER', 'fullName': 'Frederiksberg University Hospital'}, 'officialTitle': 'Proactive Health Support - a Randomized Controlled Trial of Telephone-based Self-management Support', 'orgStudyIdInfo': {'id': 'SJ-677'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proactive Health Support', 'description': "The purpose of the intervention is to enhance patients' self-management strategies and thereby enable patients to cope with illness at home and prevent the development of those conditions, that are sensitive to preventive efforts.The intervention includes active listening, coaching and counselling and elements from case management such as assessing the need for healthcare services. Emphasis is on supporting and empowering the patient to make the necessary contacts to healthcare professionals.", 'interventionNames': ['Behavioral: Proactive Health Support']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care'}], 'interventions': [{'name': 'Proactive Health Support', 'type': 'BEHAVIORAL', 'description': 'Active listening, coaching and counselling', 'armGroupLabels': ['Proactive Health Support']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Center for Clinical Research and Prevention', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Ulla Toft, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Frederiksberg University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frederiksberg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher, Principal Investigator', 'investigatorFullName': 'Ulla Toft', 'investigatorAffiliation': 'Frederiksberg University Hospital'}}}}