Clinical Trial: Evaluation of a Specialized Therapeutic Care of Patients Presenting an Intolerance Attributed to Electromagnetic Fields

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields

Brief Summary: The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life.

Detailed Summary:

110 patients suffering from Idiopathic Environmental Intolerance attributed to electromagnetic fields (IEI-EMF) are expected in this trial.

Type of trial: Interventional multicenter study, non-randomized, with measurement before and after intervention. Each patient is his own control.

Primary outcome: Efficacy of an individual medical care on electro sensitive (IEI CEM) patients evaluated from the improvement of health status, sensitivity to electromagnetic fields (EMF) exposure, and quality of life.

Scheme:

Visit 1(T0): Patients undergo a specialized medical examination: a standardized medical record is filled in. Physicians evaluate the psychological impact of IEI-EMF and a psychotherapeutic care is proposed if necessary. Patients fill in 2 self-questionaries: quality of life (SF-36) and EMF exposure sensitivity.

After the visit 1, a symptoms self-administrated questionary n°1 is completed during 7 days.

1 month after inclusions (T1), radiofrequencies (RF) are recorded by a dosimeter worn by patients for 7 days; patient fill-in the symptoms self-administrated questionary n° 2 during the same time.

Visit 2: 6 months after inclusion, analysis of symptoms and RF exposure is restituted at patient. An adapted care is proposed.

12 months after inclusion (T12), patients complete the symptoms self-administrated questionary n°3.

Visit 3: 14 months after inclusion (T14), patients have medical examination and complete the quality of life and EMF exposure sensitivity self-qu
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome:

  • Measurement of symptoms severity [ Time Frame: At 12 months after inclusion . ]
    At month 12 months the severity of symptoms is evaluated by a self-questionary filled in during 7 days. The level of severity of each symptom occurring during a week, will be self-evaluated by the patient on the base of a 0 to 5 scale. Following the intervention we expect a reduction in the severity of symptoms described.
  • Measurement of symptoms frequency [ Time Frame: At 12 months after inclusion ]
    At month 12 months the symptoms frequency is evaluated by a self-questionary filled in during 7 days. Each symptom occurring during a week is reported by the patient allowing calculation of a frequency in symptoms appearance. Following the intervention we expect a reduction in the frequency of symptoms described.
  • Sensitivity to electromagnetic fields [ Time Frame: at 14 months ]
    At visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary.
  • Measurement of symptoms frequency [ Time Frame: At 1 month after inclusion ]
    At month 1 months the symptoms frequency is evaluated by a self-questionary filled in during 7 days. Each symptom occurring during a week is reported by the patient allowing calculation of a frequency in symptoms appearance. Following the intervention we expect a reduction in the frequency of symptoms described.
  • Measurement of symptoms severity [ Time Frame: At 1 month after inclusion ]
    At month 1 month the severity of

    Original Primary Outcome:

    • Measurement of symptoms severity [ Time Frame: At 1 month after inclusion and at 12 months. ]
      At month 1 and at 12 months the severity of symptoms is evaluated by a self-questionary filled in during 7 days. The level of severity of each symptom occurring during a week, will be self-evaluated by the patient on the base of a 0 to 5 scale. Following the intervention we expect a reduction in the severity of symptoms described.
    • Measurment of symptoms frequency [ Time Frame: At 1 month after inclusion and at 12 months. ]
      At month 1 and at 12 months the symptoms frequency is evaluated by a self-questionary filled in during 7 days. Each symptom occurring during a week is reported by the patient allowing calculation of a frequency in symptoms appearance. Following the intervention we expect a reduction in the frequency of symptoms described.
    • Sensitivity to electromagnetic fields [ Time Frame: Visit 1 (day 0)/Visit 3 (14 months) ]
      At visit 1 (day 0) and visit 3 (14 months) the EMF sensitivity is evaluated by the self-questionary.


    Current Secondary Outcome:

    • Quality of life evaluation [ Time Frame: at 14 months. ]
      At visit 3 (14 months), the quality of life is evaluated by the self-questionary (SF-36)
    • Compliance to the study design [ Time Frame: At each Visit (Day 0, Month 1, Month 6 and month 14) ]
    • Quality of life evaluation [ Time Frame: day 0 ]
      At visit1 (day 0), the quality of life is evaluated by the self-questionary (SF-36)


    Original Secondary Outcome:

    • Quality of life evaluation [ Time Frame: At visit1 (day 0) and visit 3 (14 months) . ]
      At visit1 (day 0) and visit 3 (14 months) the quality of life is evaluated by the self-questionary (SF-36)
    • Compliance to the study design [ Time Frame: At each Visit (Day 0, Month 1, Month 6 and month 14) ]


    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: April 24, 2013
    Date Started: March 2012
    Date Completion:
    Last Updated: July 31, 2016
    Last Verified: July 2016