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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03262428
Other study ID # 69HCL17_0480
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 14, 2018
Est. completion date June 27, 2019

Study information

Verified date August 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The management of chronic conditions is a challenge for health systems worldwide, particularly in the context of an aging population, and requires urgent improvement of health services. Integrated care and patient empowerment represent promising solutions: offering tailored self-management support in a collaborative framework led to good results in several clinical contexts. Yet, large scale implementation remains a challenge. An important limitation of existing solutions is a lack of utilization of behavioural and communication theory for identifying the dynamics of pluridisciplinary collaboration and the interactive effects of the activities performed by several actors involved in self-management support in a given chronic condition. A second limitation is not involving all relevant actors in the development of health service improvement solutions, which leads to limited programme adoption and sustainability in routine care.

This study is part of a project that proposes to address these limitations and develop and interdisciplinary model of collaborative care in the self-management of chronic conditions (CoSMaS) that adopts a community-based participative approach. CoSMaS-ql is a qualitative study that will consist of semi-structured interviews with several types of stakeholders: patients, caregivers, and health care professionals of different specialties (e.g. general practitioners, nurses, specialist consultants, pharmacists). The main objective of the study is to explore the experiences and of patients, caregivers, and HCPs on how self-management support is currently delivered in asthma, cancer and stroke (content, communication, organisation of care), their needs related to self-management support provision, and envisaged solutions for improving current practice. Three different chronic conditions will be targeted: asthma, breast cancer and stroke. The qualitative data will be analysed via grounded-theory and template analysis. It will inform the development of a theoretical model of collaborative self-management support in chronic conditions. It will also result in three profiles describing 'real' versus 'ideal' care processes, which will represent needs assessment stages for future health services improvement interventions in the three conditions.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date June 27, 2019
Est. primary completion date June 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility PATIENTS

Inclusion Criteria:

- having (had) one of the health conditions targeted.

- age >18 years (in order to have had the opportunity to achieve full transition from parent/caregiver-managed to self-managed care),

- at least 1 year since diagnosis (in order to have had sufficient time to experience adjustments to their condition on the long term), and

- at least 1 consultation with an HCP of any specialty in the past year (in order to ensure minimum 1 recent experience of care they could reflect on).

Exclusion Criteria:

- unable to communicate in French

- level of severity of health condition or comorbidities making participation in the study too burdensome

CAREGIVERS:

Inclusion Criteria:

- nominated by a participating patients as principal caregiver

Exclusion Criteria:

- none

HEALTH CARE PROFESSIONALS :

Inclusion Criteria:

- at least 1 year of experience working in one of the 3 chronic conditions targeted (irrespective of the number of patients consulted)

Exclusion Criteria:

- none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Semi-structured interviews
Patients, caregivers and health care professionals involved in self-management support will be sought via patient organizations and professional organizations in the region. Study information materials will be provided to these organizations for dissemination to their members, providing also contact details of the study team for interested individuals to register their interest and provide basic eligibility and screening information. Selected participants will be invited to take part in a face-to-face or telephone interview about (supporting) self-management. Data collection will consist of semi-structured interviews conducted either face-to-face or by telephone.

Locations

Country Name City State
France EA 7425 HESPER - Health Services and Performance Research, Université Claude Bernard Lyon 1 Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Experiences and views of patients, caregivers, and health care professionals involved in the long-term management of asthma, cancer and stroke about real and ideal practices in collaborative self-management support. Interviews will be semi-structured and follow a topic guide designed to explore participants' goals, behaviours and determinants, perceptions of others' goals and behaviours, communication processes, tools used in self-management, support, and communication, and their vision on optimal processes and ways to implement them. Caregivers will be interviewed separately on their experiences of caregiving and self-management support by HCPs. HCPs will be interviewed regarding their experiences of providing care in one or more of the 3 chronic conditions (depending on their experience and time constraints) and their thoughts on collaborating with other professionals and solutions for integrated care and ensuring continuity of care. About 60 minutes
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