Care 4 Ourselves - person-centered support for people with chronic heart failure and / or obstructive pulmonary disease.
| ISRCTN | ISRCTN55562827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55562827 |
| Secondary identifying numbers | 154881 |
- Submission date
- 14/01/2015
- Registration date
- 30/03/2015
- Last edited
- 05/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Person-centred care (PPC) is the name given to a partnership between patients/carers and professional care givers. The starting point is the patient’s story, followed by physical examination and tests. Then a care plan is created, with goals and strategies. PCC is based on four ‘pillars’: personal health plan, educational package, coaching & counselling, symptoms & signs.
The aim of this study is to access whether PCC can work for patients with chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) and their informal care givers and whether this can help improve quality of life and cope more effectively with the diseases. The goal is to enable patients and their informal carers to understand COPD and/or CHF and the therapy better, to identify their own resources to help coping and living with their chronic illness thanks to a dialogue and partnership between health carer and patient. This will be an advice-only service.
Who can participate?
Adults over 50 admitted to hospital with worsening symptoms of COPD and/or CHF
What does the study involve?
Participants are randomly allocated to one of two groups. The ‘intervention’ group will receive usual care (regular care provided within the health system) plus a PCC nurse-led intervention. The ‘control’ group will receive usual care.
What are the possible benefits and risks of participating?
Nor provided at time of registration
Where is the study run from?
Gothenburg University Centre for Person-Centred Care (Sweden)
When is the study starting and how long is it expected to run for?
From October 2013 to December 2015
Who is funding the study?
Gothenburg University Centre for Person-Centred Care
Who is the main contact?
Professor Karl Swedberg
Contact information
Scientific
Box 457
Gothenburg
405 30
Sweden
Public
Box 457
Gothenburg
405 30
Sweden
Study information
| Study design | The overall study design is an experimental embedded research design carried out in two phases and guided by the new MRC framework. In phase I preparatory qualitative studies will be conducted, in phase II we will run a randomized controlled pilot study over a six months period. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | Care 4 Ourselves - Person-centered information and communication technology (ICT) support interventions in persons suffering from chronic heart failure and / or obstructive pulmonary disease. |
| Study acronym | C4 |
| Study objectives | The inclusion of the principles of PCC in a tele-partnership system for patients with CHF and COPD will reduce the need for medical care (primary care and hospital re-admission) amongst these patients by improving self-management, self-efficacy and collaboration in the process of care. |
| Ethics approval(s) | The Regional Ethical Review Board in Gothenburg, Box 401 405 30 Gothenburg, 17/12/2014, ref: DN 687 |
| Health condition(s) or problem(s) studied | Patients suffering from chronic heart failure and/or chronic obstructive pulmonary disease. |
| Intervention | The intervention consists of a communication and on-going dialogues between patients, their informal carers and tele-support nurses. The communication with the patient will be based on the principles of person-centred communication (listening, open questions, reflective listening and summarising of narrative). The intervention group will thus receive usual care (regular care provided within the health system) plus a PCC nurse-led intervention. The control group will receive usual care. |
| Intervention type | Other |
| Primary outcome measure | Primary outcome measure: Self-efficacy, measured at baseline, three and six months. Improved: Increase in Self-efficacy> 5 units at 6 months and has not been re-admitted to hospital Worsened: Death or re-admitted to hospital within 6 months or a decrease in self-efficacy> 5 units. Measurement scales: General Self-Efficacy Scale, Cardiac Self-Efficacy Scale Unchanged: Self-efficacy has neither improved or deteriorated |
| Secondary outcome measures | 1. Number of re-admissions 2. Change in Self-Efficacy 3. Health care utilization, measured as the number of re-admissions, and unscheduled outpatient visits duce unplanned visits to hospital and/or vårdcentral due to symptoms of COPD and CHF |
| Overall study start date | 01/10/2013 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 220 |
| Total final enrolment | 221 |
| Key inclusion criteria | 1. History of confirmed diagnosis of COPD and /or CHF 2. Admission to hospital for relapse /worsening symptoms of COPD and/or CHF 3. Age: ≥ 50 4. National registration within the Västra Götaland Region (VGR) 5. Owning a phone and current subscription to a telephone service provider |
| Key exclusion criteria | 1. Severe hearing impairment that prevents patient from using a telephone or other communication device 2. Patient has no registered address 3. Any severe disease with an expected survival < 12 months 4. Cognitive impairment - Short Portable Mental Status Questionnaire SPMSQ score >6 5. Ongoing documented diagnosis of alcohol or drug abuse 6. Other disease that can interfere with follow-up (e.g. severe depression, other severe mental illness) 7. Patient participating in another randomized study |
| Date of first enrolment | 17/12/2014 |
| Date of final enrolment | 30/06/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centre
405 30
Sweden
Sponsor information
University/education
Box 457
Visiting address:
Arvid Wallgrens backe (Hus 1)
Gothenburg
405 30
Sweden
| Website | http://gpcc.gu.se/english |
|---|---|
"ROR" |
https://ror.org/01tm6cn81 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Research results will be published in international scientific journals and presented at international conferences after completion of data analysis. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/08/2018 | Yes | No | |
| Results article | CHF subgroup analysis results | 01/06/2020 | 02/12/2019 | Yes | No |
| Other publications | subgroup analysis | 01/03/2021 | 22/06/2021 | Yes | No |
| Other publications | Qualitative analysis | 02/03/2016 | 04/04/2023 | Yes | No |
| Protocol (other) | 04/04/2023 | No | No | ||
| Results article | Self-efficacy and healthcare costs | 08/11/2023 | 05/06/2024 | Yes | No |
Editorial Notes
05/06/2024: Publication reference added.
04/04/2023: The following changes were made to the trial record:
1. Publication reference added.
2. A link to the protocol file was added.
22/06/2021: Publication reference added.
02/12/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the original results reference.
03/09/2018: Publication reference added.
