NCT03262428

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

April 14, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

August 24, 2017

Last Update Submit

August 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Patients

Patients with asthma, breast cancer, and stroke living in the Rhône Alpes region

Other: Semi-structured interviews

Caregivers

Caregivers of patients with asthma, breast cancer, and stroke living in the Rhône Alpes region

Other: Semi-structured interviews

Health care professionals

Health care professionals involved in the care of patients with asthma, breast cancer, and stroke living in the Rhône Alpes region

Other: Semi-structured interviews

Interventions

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.

CaregiversHealth care professionalsPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants will be patients, caregivers and health care professionals in the Rhône Alpes region involved in self-management support in cancer, asthma or stroke.

You may qualify if:

  • 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).

You may not qualify if:

  • unable to communicate in French
  • level of severity of health condition or comorbidities making participation in the study too burdensome
  • CAREGIVERS:
  • \- nominated by a participating patients as principal caregiver
  • \- none
  • HEALTH CARE PROFESSIONALS :
  • \- at least 1 year of experience working in one of the 3 chronic conditions targeted (irrespective of the number of patients consulted)
  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EA 7425 HESPER - Health Services and Performance Research, Université Claude Bernard Lyon 1

Lyon, 69373, France

Location

MeSH Terms

Conditions

AsthmaBreast NeoplasmsStroke

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 25, 2017

Study Start

April 14, 2018

Primary Completion

June 27, 2019

Study Completion

June 27, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations