Use of the Individual Challenge Inventory Tool (ICIT) by General Practitioners

Subjective Health Complaint Clinical Trial

— ICIT  

Official title:

Can the Use of the Conversation Tool Individual Challenge Inventory Tool (ICIT) by General Practitioners Increase Coping of the Patients?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128019
• Other study ID #: NSD368367
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Many patients in general practice present symptoms that do not refer to specific pathology. We refer to these patients at Medical Unexplained Physical Symptoms (MUPS). Practice and research have well documented that these patients frustrate most General Practitioners (GPs). They also produce a lot of unnecessary investigations and are overrepresented on sick-listing. The conversational tool Individual Challenge Inventory Tool (ICIT) offers an aid for the GPS to the consultation and aims to increase the patients' coping abilities with their health challenges. The aim of the study is to investigate whether patients experience such increased coping following a session of consultations with their GP based on ICIT.

Description:

The study is a Cluster Randomized Controlled Trial (cRCT) with GPs as clusters. We plan to includ 50 GPs to participate as intervention group and 50 GPs as controls. Each cluster will include 10 patients. GPs in the intervention group will be trained in the use of ICIT through a 30 hours course, partly digital and partly in presence. The participants will receive lectures on the background for the conversation tool, and the study, and will practice on each other. At the end of the study, also the 50 GPs of the control group will be invited to an identical course.

The outcome of the study is any changes of the patients coping abilities. If the symptoms cannot be healed, a goal for the patients will be to reduce the impact of the symptoms. In practice, this is to reuptake normal activities, including work, in spite of pain, fatigue or mood disturbances. Through the ICIT, the patients will be challenged to look at themselves in a broader spectrum and decide for themselves which activities are possible to reuptake and making a thorough plan for doing so.

The patients will be treated by their regular GP across several meetings and they will agree on a specific plan across weeks or months to achieve their individual goal.

The patients of the GPs in the control group will represent identical medical symptoms and will be treated and followed by their GP as usual. They will, however, be informed and asked to consign to participate in the study, and will respond to the same questionnaires as the patients in the intervention group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: February 28, 2023
• Est. primary completion date: May 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

• Patients must have a condition the GP deems as MUPS (unspecific og generalized pain, fatigue or mood disturbances without being depressed)

• Patients must be deemed satisfactory clinical examined without specific findings

• Patients must be able to speak and understand Norwegian language without interpreter

• Patients must sign on a consignment form

Exclusion Criteria:

• Patients must not have any well defined psychiatric diagnosis

• Patients must not have any alcohol or drug abuse

• Patients must not be using more than 10 mg Benzodiasepine per day

Related Conditions & MeSH terms

• Subjective Health Complaint

Intervention

Behavioral:
• ICIT
Patients in the intervention group will receive a number of consultations with their GP based on the ICIT

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Single question	Patients will be asked about their own anticipation of return to work	One year
Primary	Patients' assessment of personal quality of life	Patients Global Impression of Change (PGIC)	One year
Primary	Patients' experiences at the encounter	Mean change on score at the Patient Experiences Questionnaire (PEQ)	One year
Secondary	The primary outcome is any change in patient's coping strategies	Mean change on score at the Patient Activation Measure (PAM) in both groups	One year