AsthmaCoSMaS-qlNCT03262428
Collaborative Self-Management Support in Chronic Conditions - Qualitative Study
An observational study of Asthma and Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Breast Cancer, Stroke
- What is being tested?
- Semi-structured interviews
- How many people
- 109 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2018to 27 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
- nominated by a participating patients as principal caregiver
- at least 1 year of experience working in one of the 3 chronic conditions targeted (irrespective of the number of patients consulted)
Who cannot join
- unable to communicate in French
- level of severity of health condition or comorbidities making participation in the study too burdensome
- CAREGIVERS:
- none
- HEALTH CARE PROFESSIONALS :
- none
Trial locations and contacts
1 site in 1 country.
France1 site
EA 7425 HESPER - Health Services and Performance Research, Université Claude Bernard Lyon 1
Lyon, 69373
About this study
Official title: Collaborative Self-Management Support in Chronic Conditions: a Qualitative Study of Patients', Caregivers' and Health Care Professionals' Views and Experiences of Integrated Care in Asthma, Breast Cancer and Stroke
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.
- Conditions
- Asthma, Breast Cancer, Stroke
- Being tested
- Semi-structured interviews
- Medical subject headings
- Asthma, Breast Neoplasms, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with asthma, breast cancer, and stroke living in the Rhône Alpes region Receives: Other: Semi-structured interviews | |
| Caregivers | Caregivers of patients with asthma, breast cancer, and stroke living in the Rhône Alpes region Receives: 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 Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: About 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start14 Apr 2018
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262428
- Sponsor's protocol ID
- 69HCL17_0480
- Acronym
- CoSMaS-ql
- Status last verified
- Aug 2019
- First submitted
- 24 Aug 2017
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Self-Management Support in Chronic Conditions: a Qualitative Study of Patients', Caregivers' and Health Care Professionals' Views and Experiences of Integrated Care in Asthma, Breast Cancer and Stroke
- ClinicalTrials.gov ID
- NCT03262428
- Acronym / sponsor ID
- CoSMaS-ql / 69HCL17_0480
- Conditions
- Asthma, Breast Cancer, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Apr 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Semi-structured interviewsPatients with asthma, breast cancer, and stroke living in the Rhône Alpes region |
| Caregivers | – | Other: Semi-structured interviewsCaregivers of patients with asthma, breast cancer, and stroke living in the Rhône Alpes region |
| Health care professionals | – | Other: Semi-structured interviewsHealth care professionals involved in the care of patients with asthma, breast cancer, and stroke living in the Rhône Alpes region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
- nominated by a participating patients as principal caregiver
Key exclusion criteria (6 listed)
- unable to communicate in French
- level of severity of health condition or comorbidities making participation in the study too burdensome
- none
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semi-structured interviewsPatients, 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. | Other | Caregivers, Health care professionals, Patients |
Primary outcome
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.
Time frame: About 60 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Individual participant dataSharing planned: No
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: About 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.