Condition category
Circulatory System
Date applied
31/10/2013
Date assigned
12/11/2013
Last edited
08/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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, both men and women, admitted to hospital care at least two times during the last 12 months.

What does the study involve?
All patients will report daily on symptoms, measurements, and intake of medications using a digital pen and a Health Diary form. The patients will 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?
The study started in November 2013 and will run for three years. Each patient will be included in the study for 12 months.

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

Trial website

https://www.sics.se/halsodagboken

Contact information

Type

Scientific

Primary contact

Dr Leili Lind

ORCID ID

Contact details

SICS East Swedish ICT &
Department of Biomedical Engineering
Linköping University
Linköping
58185
Sweden
leili.lind@liu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

The eHealth Diary

Study hypothesis

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

Regional Ethical Review Board in Linköping, Sweden, 17/09/2013

Study design

Intervention non-randomized single-centre clinical study compared with expected outcomes

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (available in Swedish)

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Number of hospital admissions
2. Healthcare costs
3. Mortality

All outcomes measured at 12 months using patient records/administrative registers.

Secondary outcome measures

1. Health-related quality of life – at baseline, 1, 6 and 12 months (questionnaires)
2. Patients’ ability to handle the technology and method - at 1, 6 and 12 months (questionnaires)
3. Patients’ participation in their own care - at baseline, 1, 6 and 12 months (questionnaires)
4. Patients’ knowledge of their illness - at baseline, 1, 6 and 12 months (questionnaires)
5. Patients’ feeling of security - at baseline, 1, 6 and 12 months (questionnaires)
6. Deterioration and exacerbations - at baseline, 1, 6 and 12 months (patient records)

Overall trial start date

11/11/2013

Overall trial end date

30/11/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

130

Participant 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

Recruitment start date

11/11/2013

Recruitment end date

30/11/2016

Locations

Countries of recruitment

Sweden

Trial participating centre

SICS East Swedish ICT &
Linköping
58185
Sweden

Sponsor information

Organisation

Linköping University (Linköpings universitet) (Sweden)

Sponsor details

Department of Biomedical Engineering &
Department of Medical and Health Sciences
Linköping
58185
Sweden

Sponsor type

University/education

Website

http://www.imt.liu.se/

Funders

Funder type

Government

Funder name

The County Council of Östergötland (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The European Regional Development Fund through the NovaMedTech venture (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish ICT Research (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes