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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03623178
Other study ID # ID 2017-01087
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date April 1, 2019

Study information

Verified date August 2018
Source University Hospital, Geneva
Contact Louise Penzenstadler, MD
Phone +41 22 3725750
Email Louise.E.Penzenstadler@hcuge.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

According to the World Health Organization the population suffering from addiction problems is increasing. This population is characterized by multiple needs at the medico-psychosocial level. However, some of these patients, a particular subgroup that we are going to be interested in the so-called "high need" user group, find it difficult to access and stay in outpatient treatment programs. Persons with substance use disorder often present a chaotic use of the health system, including a high number of hospitalizations in times of crisis. These individuals also show very low utilization of health care services, accompanied by social marginalization. This can be related to relapses and poor social functioning. A high number of relapses occur particularly at the end of hospitalization. Community Interventions, such as Assertive Community Treatment (ACT) should increase the adherence of these patients to treatment by accompanying them in the community and helping them during sensitive and crisis periods. One of the objectives of the study is to evaluate the impact of ACT on the time until service disengagement, measuring treatment adherence. The secondary objectives of this study will be to see the effect of ACT on duration and type of hospitalizations, as well as the number of emergency room visits. The investigators will focus on the impact of ACT on the participant's medico-psycho-social network, substance use and other psychological variables. The investigators will also evaluate his or her psychiatric symptoms and global and social functioning. Life satisfaction and satisfaction with the care received will also be measured. The investigators will compare the population treated with ACT with sex, age and substance-matched controls which do not respond to ACT inclusion criteria chosen from new admissions of our addictology consultation. The study will investigate this through questionnaires at the beginning of care, at three months, six months and 12 months after the start of the ACT intervention.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date April 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Substance use disorder

- Competent subjects, able to give informed consent

- French speaking

Exclusion Criteria:

- Evidence of organic brain disease or learning disability based on the chart review.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assertive Community Treatment
The intervention program is a type of very flexible community treatment. This is facilitated by a small case load ratio per health care professional (1:10). The healthcare workers are specialized in SUD treatment. The time of the intervention differs, there is no prefixed limitation but the duration of the intervention depends on the goals agreed on with the patient. The main objective of this intervention is to ensure an adherence to an addiction treatment program and establish or consolidate a stable healthcare and social network for the patient. The intervention aims to prevent service disengagement. The healthcare workers will explore specific patient needs and ensure that health and social services are better coordinated to fit their needs.
Treatment As Usual
The treatment as usual is the intervention given in our outpatient addictology unit. It consists of an individual treatment program at our outpatient unit with regular appointments with psychiatrists and nurses. The patient can also take part in therapeutic groups and receive help from a psychologist for a targeted program or psychotherapy. The multidisciplinary team also comprises a social worker and an occupational therapist.

Locations

Country Name City State
Switzerland Service d'addictologie, HUG Geneva

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Patient satisfaction with Assertive Community Treatment Patient satisfaction with Assertive Community Treatment (very satisfied, satisfied, more or less satisfied, not satisfied at 3, 6, 12 months
Other Duration of Assertive Community Treatment intervention Daily contact log (Relevé quotidien des contacts (RQC)) in minutes spent with patient at 12 months
Other Type of Assertive Community Treatment intervention Daily contact log (Relevé quotidien des contacts (RQC)): documentation of type of activity done with patient at 12 months
Primary Treatment adherence Number of days until service disengagement at 12 months
Secondary Service use Number of hospital admissions and number of days in hospital at 12 months
Secondary Patient network Number of persons in network 0, 3, 6, 12 months
Secondary Number of ER visits Number of ER visits reviewed on patient file 0, 3, 6, 12 months
Secondary Addictive behaviour Alcohol, Smoking and Substance Involvement Screening Test (ASSIST. V.3 French) 0, 3, 6, 12 months
Secondary General psychiatric symptoms Health of Nation Outcome Scale - French version (HoNOS-F): scores 0 - 52 (higher score = more psychiatric symptoms) 0, 3, 6, 12 months
Secondary Global Functioning World Health Organization Disability Assessment Schedule (WHODAS) 0, 3, 6, 12 months
Secondary General life satisfaction: Satisfaction With Life Scale Satisfaction With Life Scale: scores 5 - 35 (higher score = higher life satisfaction) 0, 3, 6, 12 months
Secondary Advance directives written by the participant Advance directives written by the participant (yes - no) at Baseline
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