The eHealth Diary: digital pen telemonitoring of patients with advanced chronic obstructive pulmonary disease (COPD) and heart failure within specialised home care
| ISRCTN | ISRCTN34252610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34252610 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/10/2013
- Registration date
- 12/11/2013
- Last edited
- 03/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
This study aims to investigate whether the use of digital pen technology for reporting of symptoms and measurement values from the home care patient to the professional care provider can improve the care of patients with severe chronic obstructive pulmonary disease (COPD) and/or heart failure (HF).
Who can participate?
Patients > 65 years admitted to hospital care at least two times during the last 12 months
What does the study involve?
All patients report daily on symptoms, measurements, and intake of medications using a digital pen and a Health Diary form. The patients also fill in questionnaires related to quality of life and the technology and method used.
What are the possible benefits and risks of participating?
Reporting on one's health condition each day will support the professional care providers to detect early signs of worsening of the health condition. Possible risks of being included in the study are that it can be tiresome to fill in the questionnaires.
Where is the study run from?
The study will be performed at the hospital-based home care clinic, Linköping University Hospital (Sweden).
When is the study starting and how long is it expected to run for?
November 2013 to December 2017
Who is funding the study?
The study is funded by the County Council of Östergötland, The European Regional Development Fund through the NovaMedTech venture and the Swedish ICT Research (Sweden).
Who is the main contact?
Dr Leili Lind
Leili.Lind@liu.se
Contact information
Scientific
SICS East Swedish ICT & Department of Biomedical Engineering
Linköping University
Linköping
58185
Sweden
| leili.lind@liu.se |
Study information
| Study design | Intervention non-randomized single-centre clinical study compared with expected outcomes |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet (available in Swedish) |
| Scientific title | Telemonitoring of patients with advanced COPD and heart failure within specialised home care - based on digital pen technology and a Health Diary form |
| Study acronym | The eHealth Diary |
| Study objectives | The hypothesis is that special home healthcare and use of the telehealth system will detect early signs of deterioration of heart failure and COPD and monitor drug intake, and thereby decrease acute hospital re-admissions and increase the patients quality of life. |
| Ethics approval(s) | Regional Ethical Review Board in Linköping, Sweden, 17/09/2013 |
| Health condition(s) or problem(s) studied | COPD and/or heart failure |
| Intervention | This is a non-randomized single-centre study following an intervention group only. Expected outcomes will be calculated based on historical data from patients with the same characteristics out of data from our administrative register. The expected outcomes will be compared with the actual from our intervention group. This method is inspired from a discontinuity regression model, which is an alternative when randomisation is not feasible due to logistic and ethical reasons. Therefore this is an intervention clinical study compared with expected outcomes. Study patients will report daily on various symptoms and measurement values (such as shortness of breath, cough, mucous, weight, blood pressure, pulse, oxygen saturation) and intake of p.r.n. medications, using a digital pen and a Health Diary form. The Health Diary form also allows free text messages from the patients. Healthcare personnel will monitor the system and incoming patient reports on a daily basis. Alarms will be generated if a patient reports values outside of predetermined limits or if a patient fails to send in reports. Patients will be asked to fill in the following questionnaires: (Swedish versions of) St George's Respiratory Questionnaire/Minnesota Living with heart failure questionnaire, the ED-5Q questionnaire and the SF-36 (at baseline, 1, 6 and 12 months), and eHealth Diary-related questionnaires (at 1, 6 and 12 months). COPD patients will be asked to also fill in mMRC and COPD Assessment Test (CAT) at baseline. |
| Intervention type | Other |
| Primary outcome measure | All outcomes measured at 12 months using patient records/administrative registers: 1. Number of hospital admissions 2. Healthcare costs 3. Mortality |
| Secondary outcome measures | 1. Health-related quality of life, measured using questionnaires at baseline, 1, 6 and 12 months 2. Patients ability to handle the technology and method, measured using questionnaires at 1, 6 and 12 months 3. Patients participation in their own care, measured using questionnaires at baseline, 1, 6 and 12 months 4. Patients knowledge of their illness, measured using questionnaires at baseline, 1, 6 and 12 months 5. Patients feeling of security, measured using questionnaires at baseline, 1, 6 and 12 months 6. Deterioration and exacerbations, measured using patient records at baseline, 1, 6 and 12 months |
| Overall study start date | 11/11/2013 |
| Completion date | 02/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 130 |
| Key inclusion criteria | Current inclusion criteria as of 08/05/2014: 1. Patients (men and women) > 65 years diagnosed with COPD and/or heart failure 2. With >= 2 hospital admissions during the last 12 months Previous inclusion criteria: 1. Patients (men and women) > 65 years diagnosed with COPD and/or heart failure 2. With >= 3 hospital admissions due to COPD/heart failure during the last 12 months |
| Key exclusion criteria | 1. Dementia/other cognitive impairment or psychotic illness 2. Lack of ability to understand Swedish 3. Severe hearing loss 4. Underwent surgery in the last 6 months or surgery planned in the next 6 months 5. Other life-threatening illness |
| Date of first enrolment | 11/11/2013 |
| Date of final enrolment | 30/11/2016 |
Locations
Countries of recruitment
- Sweden
Study participating centre
58185
Sweden
Sponsor information
University/education
Department of Biomedical Engineering &
Department of Medical and Health Sciences
Linköping
58185
Sweden
| Website | http://www.imt.liu.se/ |
|---|---|
"ROR" |
https://ror.org/05ynxx418 |
Funders
Funder type
Government
No information available
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
03/11/2017: The overall trial end date was changed from 30/11/2016 to 02/12/2017.
