Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
Same as current

Summary

Conditions
  • Cardiac Insufficiency
  • Diabetes Mellitus - Type 2
  • Hypercholesterolemia
  • Hypertension
  • Ischemia
  • Severe Mental Disorder
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Patients who meet the inclusion criteria will be identified and invited to participate by their general practitioner. Patients who agree to partcipate will be invited to a screening consultation focusing on selected somatic diseases. Patients who are diagnosed with one or more of the selected somatic diseases will be included in the intervention, which consists of individualized courses of treatment focusing on initiation and maintenance of medical treatment and complying with current clinical guidelines and course programmes. The intervention is planned to run for one year.Masking: None (Open Label)Primary Purpose: Screening

Participation Requirements

Age
Between 36 years and 65 years
Gender
Both males and females

Description

Design, materials and methods: The project is divided in two phases. In Phase 1 the project's intervention is developed; in Phase 2 the intervention is tested. Phase 2 will be conducted as a feasibility study. Recruitment: Based on experience from previous studies, we know the target group can be di...

Design, materials and methods: The project is divided in two phases. In Phase 1 the project's intervention is developed; in Phase 2 the intervention is tested. Phase 2 will be conducted as a feasibility study. Recruitment: Based on experience from previous studies, we know the target group can be difficult to recruit and maintain in a course of treatment. We expect that 10-15 patients belonging to each provider-number will meet the project's inclusion criteria. To obtain sufficient patients for the project, we aim to include 20 general practitioners (individual provider-numbers). Accordingly, it is realistic to assume that around 75 patients undergo screening in general practice. Recruitment of general practitioners will be done by sending written information about project participation and an invitation to participate. Only general practitioners who have one or several practice nurse(s) will be invited. The written invitation will be followed by a telephone call to all invitees to identify those practitioners wishing to participate. Intervention: Phase 1: Development of intervention: The aim of Phase 1 is to design an intervention based on the experiences and perspectives of the involved stakeholders regarding how to optimize detection and treatment of somatic disease among persons with severe mental disease. The project rests on the fundamental idea that it is crucial to involve all relevant stakeholders as early as in the development phase if the intervention is to be effective and feasible to implement in practice. This phase includes 1) meetings with key stakeholders in the field, 2) observations and interviews within the Mental Health Centre Copenhagen and Copenhagen Municipality, 3) multiple project meetings involving all sectors in the project as well as on-going monitoring by the project group. Phase 2: Testing of the intervention: The intervention is divided in two parts: a screening intervention and a treatment intervention. The testing of the interventions is conducted as a feasibility study. Evaluation: The evaluation is twofold: Evaluation of the effect of the intervention Evaluation of the implementation process

Tracking Information

NCT #
NCT03428308
Collaborators
  • The City of Copenhagen
  • Mental Health Centre Copenhagen
  • Research Unit Of General Practice, Copenhagen
  • Bispebjerg Hospital
Investigators
Study Director: Ane F Bendix, MD Intersectoral Research Unit for Health Services