Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
154881
Study information
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.
Acronym
C4
Study hypothesis
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
The Regional Ethical Review Board in Gothenburg, Box 401 405 30 Gothenburg, 17/12/2014,
ref: DN 687
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
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/10/2013
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
220
Participant 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
Recruitment start date
17/12/2014
Recruitment end date
30/06/2015
Locations
Countries of recruitment
Sweden
Trial participating centre
Gothenburg University Centre for Person-Centred Care
Gothenburg
405 30
Sweden
Sponsor information
Organisation
Gothenburg Center for Person-Centred Care Research
Sponsor details
Box 457
Visiting address:
Arvid Wallgrens backe (Hus 1)
Gothenburg
405 30
Sweden
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Gothenburg Center for Person-Centred Care Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Research results will be published in international scientific journals and presented at international conferences after completion of data analysis.
Intention to publish date
31/12/2016
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30169539