Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-03-07 @ 4:33 PM
Study NCT ID:
NCT03622151
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2018-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Homeless Population and Mental Health: Impact of Primer la Llar Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention group (housing first model program) and control group (treatment as usual).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-29', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-08-04', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence and gravity of psychotic symptoms in both groups', 'timeFrame': 'Up to 21 months', 'description': 'PANSS scale (Positive And Negative Syndrome Scale). Subscales: 1. PANSS-P-Positive (7 ítems): range 7-49 (minimum and maximum scores) 2. PANSS-N-Negative (7 ítems). Range: 7-49. 3. PANSS-PG- general psychopathology (16 ítems). Range: 16-112. Higher values represent a worse outcome. Subscales are summed to compute a total score.'}, {'measure': 'Prevalence and gravity of anxious symptoms in both groups', 'timeFrame': 'Up to 21 months', 'description': 'HARS scale (Hamilton Anxiety Rating Scale). Total range:0-56. Higher values represent a worse outcome.'}, {'measure': 'Prevalence and gravity of depressive symptoms in both groups', 'timeFrame': 'Up to 21 months.', 'description': 'HDRS scale (Hamilton Depression Rating Scale). Total range: 0-52. Higher values represent a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Changes in number of visits to the emergency room/health center/specialist doctors', 'timeFrame': 'Up to 21 months', 'description': 'To see if there are increases or decreases in use of general and specific health services; questionnaire on use of services.'}, {'measure': 'Basic skills of daily life', 'timeFrame': 'Up to 21 months', 'description': 'BELS scale (Basic everyday living skills). Range subscales:\n\nself-care (0-40) domestic skills (0-28) community skills (0-16) and activity and social relations (0-20). Higher value reports better outcome. Subescales are summed to compute a total score.'}, {'measure': 'Sociodemographic and psychopathological description of both groups', 'timeFrame': 'Up to 21 months', 'description': 'Number of participants from each country, average age, number of men and women, number of participants with a problem of substance abuse or mental health, etc.\n\nAssessed by a questionnaire about clinical and socio-demographic items.'}, {'measure': 'Number of participants with an alcohol abuse problem assessed by Audit test', 'timeFrame': 'Up to 21 months', 'description': 'Changes in alcohol abuse in both groups Audit test (0-40). Higher value reports worse outcome.'}, {'measure': 'Number of participants with a drug abuse problem assessed by questionnaire on drug abuse', 'timeFrame': 'Up to 21 months', 'description': 'Increase or decrease on drug abuse in both groups'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mental health', 'Housing First', 'homeless'], 'conditions': ['Mental Health Disorder']}, 'referencesModule': {'references': [{'pmid': '25639993', 'type': 'BACKGROUND', 'citation': 'Aubry T, Tsemberis S, Adair CE, Veldhuizen S, Streiner D, Latimer E, Sareen J, Patterson M, McGarvey K, Kopp B, Hume C, Goering P. One-year outcomes of a randomized controlled trial of housing first with ACT in five Canadian cities. Psychiatr Serv. 2015 May 1;66(5):463-9. doi: 10.1176/appi.ps.201400167. Epub 2015 Feb 2.'}, {'pmid': '26634243', 'type': 'BACKGROUND', 'citation': 'Henwood BF, Byrne T, Scriber B. Examining mortality among formerly homeless adults enrolled in Housing First: An observational study. BMC Public Health. 2015 Dec 4;15:1209. doi: 10.1186/s12889-015-2552-1.'}, {'pmid': '29558927', 'type': 'BACKGROUND', 'citation': 'Kerman N, Sylvestre J, Aubry T, Distasio J. The effects of housing stability on service use among homeless adults with mental illness in a randomized controlled trial of housing first. BMC Health Serv Res. 2018 Mar 20;18(1):190. doi: 10.1186/s12913-018-3028-7.'}, {'pmid': '24176253', 'type': 'BACKGROUND', 'citation': 'Somers JM, Patterson ML, Moniruzzaman A, Currie L, Rezansoff SN, Palepu A, Fryer K. Vancouver At Home: pragmatic randomized trials investigating Housing First for homeless and mentally ill adults. Trials. 2013 Nov 1;14:365. doi: 10.1186/1745-6215-14-365.'}, {'pmid': '25734732', 'type': 'BACKGROUND', 'citation': "Stergiopoulos V, Hwang SW, Gozdzik A, Nisenbaum R, Latimer E, Rabouin D, Adair CE, Bourque J, Connelly J, Frankish J, Katz LY, Mason K, Misir V, O'Brien K, Sareen J, Schutz CG, Singer A, Streiner DL, Vasiliadis HM, Goering PN; At Home/Chez Soi Investigators. Effect of scattered-site housing using rent supplements and intensive case management on housing stability among homeless adults with mental illness: a randomized trial. JAMA. 2015 Mar 3;313(9):905-15. doi: 10.1001/jama.2015.1163."}]}, 'descriptionModule': {'briefSummary': 'The main goal is to evaluate the impact of the Primer La Llar housing program for the homeless population on the mental health of the participants.\n\nThe hypothesis is that the housing program, which follows Housing first model, for the homeless population has a positive impact on the mental health of the participants, compared to the group that does not receive the intervention -treatment as usual group (meaning the "positive impact" a lower score on the symptomatology scales and lower toxic intake in the group receiving the intervention).', 'detailedDescription': 'The specific objectives are:\n\nIdentify the socio-demographic and clinical characteristics of the participants.\n\nCompare the severity of psychiatric symptoms and improvement among the participants in the intervention group and the control group (depressive, anxious, psychotic or manic symptomatology, depending on the case).\n\nCompare the consumption of alcohol and drugs among the participants of both groups.\n\nCompare the basic daily life skills among the participants in both groups, as well as the improvement of them in the experimental group.\n\nCompare the use of services and between the participants of the intervention group and the control group.\n\nIntervention group receives entry to the program (which means individual and permanent housing without previous requirements such as abstinence, compliance with treatment or sobriety.\n\nControl group receives treatment as usual, as they are users of homeless population network of Barcelona.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '72 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single people, adults (exceptionally sentimental couples, friends with positive support relationship for both).\n* Long life on the street (minimum 1 year staying overnight on the street) and / or accommodation centers without linking, using them in a timely manner in the last year.\n* Social needs concurrent to the lack of housing: mental illness and / or drug abuse.\n* Functional autonomy for daily life.\n* Have regular economic income or possibility of obtaining them.\n* Sign informed consent form.\n\nExclusion Criteria:\n\n* language barrier\n* severe neurological or organic pathology\n* severe dementia\n* alcoholic dementia Wernicke Korsakoff'}, 'identificationModule': {'nctId': 'NCT03622151', 'briefTitle': 'Homeless Population and Mental Health: Impact of Primer la Llar Program', 'organization': {'class': 'OTHER', 'fullName': 'Parc Sanitari Sant Joan de Déu'}, 'officialTitle': 'Homeless Population and Mental Health: Impact of Primer la Llar Program', 'orgStudyIdInfo': {'id': 'PIC-130-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Primer la Llar Program (housing first model): to live in permanent and individual housing and receiving weekly visits from a multidisciplinary team.', 'interventionNames': ['Other: Primer la Llar program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Treatment as usual:\n\nattention from the resources of the homeless network in Barcelona.'}], 'interventions': [{'name': 'Primer la Llar program', 'type': 'OTHER', 'description': 'Housing First model: permanent housing without previous requirements such as abstinence, sobriety or compliance with treatment.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Josep Maria Haro Abad', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Parc Sanitari Sant Joan de Déu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc Sanitari Sant Joan de Déu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mental Health Nurse', 'investigatorFullName': 'Inés Campo Ferreiro', 'investigatorAffiliation': 'Parc Sanitari Sant Joan de Déu'}}}}