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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05128019
Other study ID # NSD368367
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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