Implementation of Family Involvement for Persons With Psychotic Disorders.

NCT03869177 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2023-01-04

No results posted yet for this study

Summary

This study will develop and evaluate a complex intervention to implement guidelines on family involvement for patients with psychotic disorders (F20-29 in International Classification of Diseases ICD-10) in community mental health centres, by using a cluster randomised design. Fifteen Norwegian outpatient units participate in the study, and each of them constitutes a single cluster, except for two collaborating clinics who are considered one cluster.

Of the fourteen clusters, half will receive implementation support and training immediately, whereas the other half will receive it one and a half year later. The study will assess both service level outcomes, by measuring fidelity scores, and selected outcomes for patients and relatives, by collecting questionnaires and data from central health registers and patient records. In addition, qualitative interviews will be performed with patients, relatives and health care personnel. The study will also include a cost-effectiveness analysis and a political economy analysis.

Conditions

  • Psychotic Disorders

Interventions

OTHER

Implementation support program

The IFIP intervention consists of the following elements: I. Clinical interventions 1.1 A basic level of family involvement and support 1.2 Family psychoeducation in single-family groups II. Implementation interventions 2.1 Training and guidance of health care personnel 2.2 A family coordinator 2.3 Other implementation measures

Sponsors & Collaborators

  • Oslo Metropolitan University

    collaborator OTHER
  • University Hospital, Akershus

    collaborator OTHER
  • Helse Fonna

    collaborator OTHER
  • Diakonhjemmet Hospital

    collaborator OTHER
  • Vestre Viken Hospital Trust

    collaborator OTHER
  • Oslo University Hospital

    collaborator OTHER
  • Sykehuset i Vestfold HF

    collaborator OTHER
  • Sykehuset Telemark

    collaborator OTHER_GOV
  • The Research Council of Norway

    collaborator OTHER
  • Helse Sor-Ost

    collaborator OTHER_GOV
  • University of Oslo

    lead OTHER

Principal Investigators

  • Reidar Pedersen, PhD · Professor and head of department, Centre for medical ethics,University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2021-11-30
Completion
2022-05-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03869177 on ClinicalTrials.gov