Status:
COMPLETED
Analysis of the Efficiency of a Chronic Disease Self-Management Programme in a Vulnerable Population in Five European Countries
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Ente Ospedaliero Ospedali Galliera
Erasmus Medical Center
Conditions:
Chronic Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
According to the World Health Organization (WHO), it is estimated that around 35% of women and 29% of men are affected by chronic conditions and this percentage is clearly influenced by specific risk ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Person older than 18 years of age who has one of the following condition:
- Situation 1: Isolated Caregivers
- • Caregiver: a person that takes care of someone with an illness. The caregiver may be a spouse or partner, sibling, adult child, other family member or friend of someone with a chronic illness. Caregivers might be primary or secondary caregivers and live with or separate from the person receiving care. Caregivers don´t have to suffer from a chronic disease, but they must have a vulnerability condition defined as at least one of the following criteria:
- without support network or
- without means of transport or limited access to it (without private car and without public transport near to the place of residence (more than 1 km from the house)) or
- digital isolation: without wifi or internet
- Situation 2: Vulnerable people with a chronic disease
- A chronic disease (self-reported or clinically evaluated by medical staff) according to the International Classification of Primary Care (ICPC-2): a chronic pathology with code between 70 and 99 registered in one of the 17 chapters (see Annex)
- Chronic disease that has more than six months of evolution.
- Vulnerability condition, such as:
- Elderly people (older than 65 years of age) living alone or living in a nursing home and being in a situation of social or family isolation
- Ethnic minorities (Travellers - Gens du Voyage) on a low income\*
- Legal immigrants, refugees and asylum-seekers on a low income\*. For the asylum-seekers the domicile must be known for at least 6 months
- Other vulnerable persons on a low income\* even if not included in the previous target groups.
- Low income: below the poverty line at 60 % of median standard of living for the year 2015 (see in the Annex, INSEE Première, 2017). We consider below the poverty line at 60 % the persons that are entitled to have: Revenu de Solidarité Active -RSA, Couverture Maladie Universelle Complémentaire - CMU-C, or Allocation Adulte Handicapé - AAH, or Allocation pour Demandeur d'Asile - ADA or Allocation de solidarité aux personnes âgées-ASPA. The persons that are entitled to have the Pension d'invalidité are included regardless their income. For all the others types of social allowance, the revenue should be below the poverty line at 60 % of median standard of living for the year 2015 (see in the Annex, INSEE Première, 2017).
- Illiterate individuals older than 18 years of age who are in situation 1 or 2 might be included
- Exclusion criteria:
- \- Person who could not commit to a 6-months follow-up regardless of the reason
- Person living a period of crisis (domestic violence, refugees without a stable environment, eviction, etc.).
- Basic housing needs not met (homeless or roofless).
- Diagnosed with severe mental health problems (DSM V) (e.g. psychosis…) with distorted perception of reality and/or inability to function in a group.
- Cognitive decline (e.g. Alzheimer´s), identified as a score from 0 to 42 on the "Test Your Memory" test.
- Active addictive disorders (drugs, alcohol). If addiction took place in the past but at the time of inclusion the addiction is over, the person may be included
- People without an adequate knowledge of the language of the country of residence.
- Prisoners or subjects who are involuntary incarcerated
Exclusion
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2020
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT03840447
Start Date
January 7 2019
End Date
August 27 2020
Last Update
September 30 2025
Active Locations (1)
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1
Rheumatology department
Montpellier, France, 34295