Clinical trial NCT03840447: Analysis of the Efficiency of a Chronic Disease Self-Management Programme in a Vulnerable Population in Five European Countries
Official title: Analysis of the Efficiency of a Chronic Disease Self-Management Programme in Population With Socioeconomic Vulnerability in Five European Countries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Chronic Disease
Prevention and control
Patient Education as Topic
Health Services/utilization
Program Evaluation
Cost-Benefit Analysis
Self-Efficacy
Disease Management
Health Status
Outcome Assessment (Health Care)
Self Care
Socioeconomic Factors
Poverty Areas
Chronic Disease Self-Management Programme
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Ente Ospedaliero Ospedali Galliera
name: Erasmus Medical Center
name: Asturias Public Health Service (SESPA)
First posted: 2019-02-15
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 factors, such as lifestyle indicators. The high prevalence of chronic conditions put a large burden on national budgets. The healthcare costs of chronic conditions reach 6.8% of GDP in some European countries. The economic factors are also conditioning the individuals' lifestyles, including their concerns about health and self-care as a part of their way of life. the most educated patients suffering from a chronic disorder have often better skills to manage their conditions and therefore, show better health indicators than those less educated or with lowest socioeconomic status. In addition, the former are normally more interested in participating in community-based interventions, training programmes and research actions. Thus, the impact of interventions targeted to increase self-management skills and improve health condition of individuals with chronic diseases could be extremely higher in those individuals with education and socioeconomic vulnerability traits. Several health education programs have shown positive effects in the self-management of chronic disease. The Chronic Disease Self-Management Programme is a program based on empowering people with chronic diseases to manage and control their disease. This program has been used in several countries over the past twenty years and its effectiveness has been widely demonstrated. However, this programme has not been specifically offered to people in situations of socio-economic vulnerability. The implementation of the EFFICHRONIC project, in five European countries with different health systems and socio-economic contexts, will validate the effectiveness of this program with vulnerable people with chronic diseases. Indeed, the investigators believe that the benefit of interventions aimed at increasing self-management skills and improving the health status of people with chronic diseases could be greater for people with socio-economic vulnerability characteristics.


Eligibility criteria: Inclusion Criteria:

1. Person older than 18 years of age who has one of the following condition:
2. 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
3. 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).
4. Illiterate individuals older than 18 years of age who are in situation 1 or 2 might be included

Exclusion criteria:

1. - Person who could not commit to a 6-months follow-up regardless of the reason
2. Person living a period of crisis (domestic violence, refugees without a stable environment, eviction, etc.).
3. Basic housing needs not met (homeless or roofless).
4. Diagnosed with severe mental health problems (DSM V) (e.g. psychosis...) with distorted perception of reality and/or inability to function in a group.
5. Cognitive decline (e.g. Alzheimer´s), identified as a score from 0 to 42 on the "Test Your Memory" test.
6. 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
7. People without an adequate knowledge of the language of the country of residence.
8. Prisoners or subjects who are involuntary incarcerated

Primary outcomes:
measure: Evaluate the efficacy of a 6-weeks self-management program on the quality of life by SF-12 between baseline and 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of the health status between baseline and 6 months
timeFrame: 6 months
measure: Evaluation of the wellbeing between baseline and 6 months
timeFrame: 6 months
measure: Evaluation of the heatlhy behaviour between baseline and 6 months
timeFrame: 6 months
measure: Evaluation of the communication with physician between baseline and 6 month
timeFrame: 6 months
measure: Evaluation of the self-efficacy (confidence in ability to deal with health problems) between baseline and 6 month
timeFrame: 6 months
measure: Evaluate the cost-effectiveness of the program between baseline and 6 month
timeFrame: 6 months
measure: Evaluation of the adherence to treatment according to number of sessions performed
timeFrame: 6 months
measure: Evaluate the medical error experience between baseline and 6 month
timeFrame: 6 months
measure: Evaluate the critical thinking between baseline and 6 month
timeFrame: 6 months
measure: Evaluate the improved selection of information between baseline and 6 month
timeFrame: 6 months
measure: Evaluate the impact of the program CDSMP at 6 months
timeFrame: 6 months
measure: Description of the characteristics of population included in the project
timeFrame: 6 months
measure: Assess the influence of the type of help during the baseline visit and at 6 months visit
timeFrame: 6 months
measure: Evaluation of the wellbeing between baseline and 6 months
timeFrame: 6 months
measure: Evaluation of the heatlhy behaviour between baseline and 6 months
timeFrame: 6 months
measure: Evaluation of the heatlhy behaviour between baseline and 6 months
timeFrame: 6 months
measure: Evaluation of the heatlhy behaviour between baseline and 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Rheumatology department
Study officials:
References: