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Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration (PANDA)

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ClinicalTrials.gov Identifier: NCT03035461
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Joëlle Marciano, Centre Hospitalier Intercommunal Creteil

Brief Summary:

Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".

Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.

After diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.

The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.


Condition or disease
Age Related Macular Degeneration

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Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Description of the patient's feelings [ Time Frame: up to 1 month after diagnosis ]
    A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis. they can also explain their feelings by themselves.


Secondary Outcome Measures :
  1. score of general satisfaction [ Time Frame: up to 1 month after diagnosis ]
    the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)

  2. score on a comprehension quiz on AMD [ Time Frame: up to 1 month after diagnosis ]
  3. Score on a composite score evaluating the clarity of medical explanations [ Time Frame: up to 1 month after diagnosis ]
  4. Score on a composite score evaluating the clarity of medical explanations [ Time Frame: between 6 months and 1 year of follow-up ]
  5. score of satisfaction of announcement conditions [ Time Frame: up to 1 month after diagnosis ]
  6. score of satisfaction of announcement conditions [ Time Frame: between 6 months and 1 year of follow-up ]
  7. score of satisfactions regarding the clarity of the disease course and treatment explanations [ Time Frame: between 6 months and 1 year of follow-up ]
  8. Score on the anxiety PHQ9 questionnaire [ Time Frame: between 6 months and 1 year of follow-up ]
  9. Score on the anxiety GAD7 questionnaire [ Time Frame: between 6 months and 1 year of follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of wet AMD seen in the ophtalmologic department of the CHI creteil
Criteria

Inclusion Criteria:

  • patient up to 55 years old
  • wet AMD
  • diagnostic questionnaire group: patient being announced with AMD for less than 1 month
  • disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months

Exclusion Criteria:

  • dry AMD
  • patient under 55 years old
  • patient who doesn't speak French
  • patient carrying an ophtalmologic genetic disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035461


Locations
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France
Marciano Joelle
Créteil, Creteil, France, 94000
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil

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Responsible Party: Joëlle Marciano, Orthoptist in the ophtalmologic department of the CHI Creteil, Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03035461     History of Changes
Other Study ID Numbers: PANDA
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joëlle Marciano, Centre Hospitalier Intercommunal Creteil:
diagnosis annoucement
patient's feelings

Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases