Analysis of the Efficiency of a Chronic Disease Self-Management Programme in a Vulnerable Population in Five European Countries

NCT03840447 | Completed

• 2 other identifiers: RECHMPL19_00052018-A01054-51
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of a 6-weeks self-management program on the quality of life by SF-12 between baseline and 6 months

  12-Item Short Form Health Survey (SF-12) has two components: physical composite scores (PCS) and mental composite scores (MCS). These two components measure eight concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological wellbeing). PCS and MCS are computed using the scores of twelve questions and the sum of PCS and MCS range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

  6 months

Secondary Outcomes (17)

• Evaluation of the health status between baseline and 6 months

  6 months

• Evaluation of the wellbeing between baseline and 6 months

  6 months

• Evaluation of the heatlhy behaviour between baseline and 6 months

  6 months

• Evaluation of the communication with physician between baseline and 6 month

  6 months

• Evaluation of the self-efficacy (confidence in ability to deal with health problems) between baseline and 6 month

  6 months

Study Arms (1)

Chronic Disease Self-Management programme

EXPERIMENTAL

Behavioral: Chronic Disease Self-Management programme

Interventions

Chronic Disease Self-Management programme BEHAVIORAL

The primary aim of the intervention is to achieve greater self-management of the chronic condition by changing the role of the passive citizen to empowerment in self-confidence and self-reliance. The intervention consists of a series of 6 workshops (with 7 to 8 activities), 2.5 hours each, which are held once a week for 6 weeks. One professional and one peer will volunteer together to lead a series of workshops. To this end, professionals and peers will be recruited and trained in the CDSMP principles. Over 6 workshops, citizens set realistic health goals, learn to self-manage pain and discomfort, to self-manage their diet, self-manage physical activity, mood and the way the disease influences their personal relationships. The intervention is designed to actively involve citizens.

Chronic Disease Self-Management programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \- 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.
• People without an adequate knowledge of the language of the country of residence.
• Prisoners or subjects who are involuntary incarcerated

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Ente Ospedaliero Ospedali Galliera: collaborator
• Erasmus Medical Center: collaborator
• Asturias Public Health Service (SESPA): collaborator

Study Sites (1)

Rheumatology department

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Chronic Disease; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: February 15, 2019
• Study Start: January 7, 2019
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: September 30, 2025

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)