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Home Treatment for Individuals Suffering From Severe Addictive Disorders

Primary Purpose

Substance Use Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hospital-like treatment in patients' home
standard inpatient treatment
Sponsored by
Louise Penzenstadler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Substance use disorder
  • age 18 or above
  • sufficient french language skills
  • competent subjects
  • consent to randomization progress

Exclusion Criteria:

  • organic brain disease or developmental disorder
  • non voluntary admission
  • severe somatic comorbidity
  • History of complicated substance withdrawal
  • acute suicidal ideation
  • aggressive behavior
  • acute psychiatric disease such as mania or psychosis
  • distance to center (must be reachable within 60 minutes)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Home treatment

    Standard inpatient treatment

    Arm Description

    Home visits by care staff at the same frequency as in hospital

    Inpatient treatment on hospital ward

    Outcomes

    Primary Outcome Measures

    readmission rates
    Number of readmissions to hospital during the 6 months following discharge

    Secondary Outcome Measures

    time to readmission
    Number of days between discharge and readmission during the 6 months following discharge
    length of hospitalization
    total number of days spent in hospital during the 6 months following discharge
    number of emergency room visits
    number of emergency room visits during the 6 months following discharge
    clinical outcome
    clinical outcomes measured with Health of the Nation Outcome scale (HoNOS) scoring 0 (no symptoms) to 48 (high symptom level) and the Brief Symptom Check-List (short form of the Brief Symptom Inventory), scoring 0-53 items (higher score = more symptoms). Measured at the start and end of intervention/hospital treatment.
    patient satisfaction
    Patient satisfaction measured with the S-ANQ (https://www.anq.ch/en/), a questionnaire used by all Swiss hospitals to measure patient satisfaction with treatment. The questionnaire includes 6 questions which are marked from 0 not at all satisfied to 5 = very satisfied. Scoring 0 (not at all satisfied) to 30 (very satisfied)

    Full Information

    First Posted
    September 23, 2022
    Last Updated
    September 28, 2022
    Sponsor
    Louise Penzenstadler
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05563363
    Brief Title
    Home Treatment for Individuals Suffering From Severe Addictive Disorders
    Official Title
    A Pilot Study on Home Treatment for Individuals Suffering From Severe Addictive Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Louise Penzenstadler

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Home Treatment (HT) has been successfully implemented in adult psychiatry in several countries including Switzerland. Patients with addiction problems were generally excluded even if the latter was not the main diagnosis. On the other hand, community treatments have successfully been established for these individuals. The investigators have recently offered HT to persons with severe addictive disorders which was well accepted. The investigators intend to conduct a pilot study to prepare a large-scale study if successful. The investigators intend to compare HT to treatment as usual (regular inpatient treatment) on a specialized ward with respect to readmission rates during 6 months after discharge. The data show that 70.8% of all readmissions occur during the first 6 months. Therefore, a period of 6 months is considered an adequate time interval to sufficiently answer this pilot study's question.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Pilot study, randomized, open, non-blinded
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Home treatment
    Arm Type
    Experimental
    Arm Description
    Home visits by care staff at the same frequency as in hospital
    Arm Title
    Standard inpatient treatment
    Arm Type
    Active Comparator
    Arm Description
    Inpatient treatment on hospital ward
    Intervention Type
    Other
    Intervention Name(s)
    Hospital-like treatment in patients' home
    Intervention Description
    Hospital-like treatment in patients' home. Caregivers, medical doctors and social workers will make several visits per day to the patients' home. 24/7 contact is available.
    Intervention Type
    Other
    Intervention Name(s)
    standard inpatient treatment
    Intervention Description
    Inpatient treatment on addiction ward
    Primary Outcome Measure Information:
    Title
    readmission rates
    Description
    Number of readmissions to hospital during the 6 months following discharge
    Time Frame
    6 month post-discharge
    Secondary Outcome Measure Information:
    Title
    time to readmission
    Description
    Number of days between discharge and readmission during the 6 months following discharge
    Time Frame
    6 months
    Title
    length of hospitalization
    Description
    total number of days spent in hospital during the 6 months following discharge
    Time Frame
    6 months
    Title
    number of emergency room visits
    Description
    number of emergency room visits during the 6 months following discharge
    Time Frame
    6 months
    Title
    clinical outcome
    Description
    clinical outcomes measured with Health of the Nation Outcome scale (HoNOS) scoring 0 (no symptoms) to 48 (high symptom level) and the Brief Symptom Check-List (short form of the Brief Symptom Inventory), scoring 0-53 items (higher score = more symptoms). Measured at the start and end of intervention/hospital treatment.
    Time Frame
    6 months
    Title
    patient satisfaction
    Description
    Patient satisfaction measured with the S-ANQ (https://www.anq.ch/en/), a questionnaire used by all Swiss hospitals to measure patient satisfaction with treatment. The questionnaire includes 6 questions which are marked from 0 not at all satisfied to 5 = very satisfied. Scoring 0 (not at all satisfied) to 30 (very satisfied)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Substance use disorder age 18 or above sufficient french language skills competent subjects consent to randomization progress Exclusion Criteria: organic brain disease or developmental disorder non voluntary admission severe somatic comorbidity History of complicated substance withdrawal acute suicidal ideation aggressive behavior acute psychiatric disease such as mania or psychosis distance to center (must be reachable within 60 minutes)

    12. IPD Sharing Statement

    Learn more about this trial

    Home Treatment for Individuals Suffering From Severe Addictive Disorders

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