Condition category
Circulatory System
Date applied
14/01/2015
Date assigned
30/03/2015
Last edited
30/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Seniorprofessor Karl Swedberg

ORCID ID

Contact details

Box 457
Gothenburg
405 30
Sweden

Type

Public

Additional contact

Research Assistant Birgit Heckemann

ORCID ID

Contact details

Box 457
Gothenburg
405 30
Sweden

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 measures

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

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

http://gpcc.gu.se/english

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes