Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry (SENIORHEMO)

June 7, 2023 updated by: Assistance Publique Hopitaux De Marseille

Background:

Elderly people with serious haemophilia (PwSH), i.e., with moderate or severe haemophilia, have major comorbidities due to consequences of haemophilia. Also, the comorbidities related to age are added. Despite the existence of numerous studies on the objective health status of elderly PwSH, some limitations may be stated (need to update the results in a more contemporary context, no studies conducted in France, highlighted determinants focused on demographic and clinical factors).

On the contrary, the perceived health status of elderly PwSH has been little described. Only two studies specifically addressed the quality of life (QoL) of elderly PwSH. These studies reported an altered QoL in some domains, in comparison with reference values from the general population. However, some limitations may also be stated (need to bring results in a more contemporary context, no studies conducted in France, highlighted determinants focused on clinical factors).

Since serious haemophilia is a rare disease, studies are often performed on a small number of subjects. The present project relies on the FranceCoag registry, a unique exhaustive national cohort of PwSH followed over time among whom 612 are elderly PwSH.

Objectives:

Main objective: to describe the objective and perceived health status of elderly (≥60 y.o.) PwSH from of a French exhaustive national registry, and to compare their health status with that of the French general elderly population.

Secondary objective: to identify individual (demographic, clinical, social, psycho-cognitive) and collective characteristics (related to healthcare organisation), associated with the objective and perceived health status of elderly PwSH in France.

Materials and Methods:

A national, multicentric, observational, cross-sectional study will be conducted. It will be based on the participation of elderly PwSH already included in the FranceCoag registry. Each eligible participant will receive a questionnaire to complete concerning: objective health status; perceived health status (QoL assessed by the WHOQOL-Old questionnaire); demographic data; social data; psycho-cognitive data (anxious symptoms, depressive symptoms, use of coping strategies, time perspective). Therapeutic and clinical data related to haemophilia will be collected via the FranceCoag registry database. Data concerning healthcare organisation will be collected directly from investigators of Haemophilia Treatment Centres.

The main analysis will consist in the description and comparison of the health status with reference data from the French general elderly population. Standardisation methods will be used to take into account a potential imbalance between the study population and the reference population, related to age and especially to sex, as haemophilia is a predominantly male disease.

The secondary analysis will consist in the identification of potential determinants of the health status. Structural equation models will be performed to take into account the complexity of the relationships between the determinants.

Impact of the proposal Better understanding the impact of the disease on patients' experience is essential in a systematic global perspective of health, that aims to care and support the individual not only as a patient but also as a person in his/her environment. This study based on a registry will allow to improve the knowledge by updating literature data on the health status of elderly PwSH, adding elements to the rare literature data on the perceived health status, providing data in the French specific context, and identifying both classical and more original determinants of health status of elderly PwSH. These results will be used to better identify elderly PwSH at high risk of poor health status, to propose recommendations and to set up actions to offer them an adapted support, and to elaborate new versions of public health plans dedicated to haemophilia or to rare diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

612

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU AMIENS
        • Contact:
          • Annelise VOYER
      • Annecy, France
        • Recruiting
        • CH Annecy - St Julien
        • Contact:
          • Claire REYNES
      • Besançon, France
        • Recruiting
        • CHU de Besançon
        • Contact:
          • Alexandra FOURNEL
      • Bordeaux, France
        • Recruiting
        • CHU de Bordeaux
        • Contact:
          • Sabine-Marie CASTET
      • Brest, France
        • Recruiting
        • CHU Brest
        • Contact:
          • Brigitte PAN-PETESCH
      • Caen, France
        • Recruiting
        • CHU De Caen
        • Contact:
          • Yohann REPESSE
      • Chambery, France
        • Recruiting
        • Centre Hospitalier Metropole Savoie
        • Contact:
          • Valerie GAY
      • Clermont-Ferrand, France
        • Recruiting
        • CHU clermont-ferrand
        • Contact:
          • Aurelien LEBRETON
      • Dijon, France
        • Recruiting
        • CHU de Dijon
        • Contact:
          • Fabienne GENRE VOLOT
      • La Réunion, France
        • Recruiting
        • CHU La Réunion
        • Contact:
          • Stephane VANDERBECKEN
      • Le Mans, France
        • Recruiting
        • CHU Le Mans
        • Contact:
          • Vincent CUSSAC
      • Lille, France
        • Recruiting
        • CHRU de Lille
        • Contact:
          • Antoine RAUCH
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
          • Anne LIENHART
      • Marseille, France, 13005
        • Recruiting
        • AP-HM
        • Contact:
          • Noemie Resseguier
      • Montpellier, France
        • Recruiting
        • CHU Montpellier
        • Contact:
          • Christine BIRON-ANDREANI
      • Nancy, France
        • Recruiting
        • Chu de Nancy
        • Contact:
          • Birgit FROTSCHER
      • Nantes, France
        • Recruiting
        • CHU Nantes
        • Contact:
          • Marc TROSSAERT
      • Nice, France
        • Recruiting
        • CHU de Nice
        • Contact:
          • Pierre-Simon ROHRLICH
      • Paris, France
        • Recruiting
        • AP-HP
        • Contact:
          • NA NA
      • Poitiers, France
        • Recruiting
        • CHU Poitiers
        • Contact:
          • Mathieu Puyade
      • Reims, France
        • Recruiting
        • CHU Reims
        • Contact:
          • Philippe NGUYEN
      • Rennes, France
        • Recruiting
        • CHU de RENNES
        • Contact:
          • Benoit Guillet
      • Rouen, France
        • Recruiting
        • CHU de Rouen
        • Contact:
          • Pierre CHAMOUNI
      • Saint-Étienne, France
        • Recruiting
        • CHU St Etienne
        • Contact:
          • BRIGITTE TARDY
      • Strasbourg, France
        • Recruiting
        • CHU Strasbourg
        • Contact:
          • Dominique DESPREZ
      • Toulouse, France
        • Recruiting
        • CHU Toulouse
        • Contact:
          • Marie-Lea PIEL-JULIAN
      • Tours, France
        • Recruiting
        • CHRU de Tours
        • Contact:
          • Laurent ARDILLON
      • Versailles, France
        • Recruiting
        • CH Versailles
        • Contact:
          • Emmanuelle DE RAUCOURT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elderly people with moderate or severe haemophilia in France

Description

Inclusion Criteria:

  • People with serious haemophilia, i.e., with (A or B) moderate or severe haemophilia;
  • People aged 60 years or over;
  • People included in the FranceCoag registry;
  • People followed in one of the Haemophilia Treatment Centre participating in the study;
  • People who do not oppose to participate in the study.

Exclusion Criteria:

  • People with comprehension disabilities;
  • Participants who a posteriori oppose to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly people with moderate or severe haemophilia
Other: Questionnaires
Each eligible participant will receive a questionnaire to complete concerning: objective health status; perceived health status (QoL assessed by the WHOQOL-Old questionnaire); demographic data; social data; psycho-cognitive data (anxious symptoms, depressive symptoms, use of coping strategies, time perspective)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective health status (apart from serious haemophilia)
Time Frame: 1 day
Declaration by the participant of at least one chronic disease or health issue (apart from serious haemophilia)
1 day
Perceived health status
Time Frame: 1 day
Assessed by the quality of life, which will be measured by the WHOQOL-Old questionnaire
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2022

Primary Completion (Estimated)

June 30, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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