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Completed

NCT Number: NCT05128019

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

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.

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Key information

Conditions

Medical Unexplained Physical Symptoms (MUPS) Subjective Health Complaint

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oslo

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICIT

Behavioral

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

Primary outcomes

  1. Patients' assessment of personal quality of life

    Time frame: One year

    Patients Global Impression of Change (PGIC)

  2. Patients' experiences at the encounter

    Time frame: One year

    Mean change on score at the Patient Experiences Questionnaire (PEQ)

Secondary outcomes

  1. The primary outcome is any change in patient's coping strategies

    Time frame: One year

    Mean change on score at the Patient Activation Measure (PAM) in both groups

Other outcomes

  1. Single question

    Time frame: One year

    Patients will be asked about their own anticipation of return to work

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

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

Acronym: ICIT

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 19, 2021
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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