Plain English Summary
Background and study aims
This aim of this study is to find out whether the use of Information Technology (IT), specifically a digital pen, can improve symptom control in patients with end-stage cancer who are receiving advanced palliative home care.
Who can participate?
Patients with end-stage cancer receiving advanced palliative home care, who are experiencing at least moderate pain or decreased well-being
What does the study involve?
Participants are randomly allocated into two groups. One group receives an IT system to be used for symptom reporting while the other group uses traditional ways of symptom reporting. The IT system consists of a Symptom Diary form together with digital pen technology to capture symptom assessments in the home of the patient. The Symptom Diary includes assessment of pain intensity and well-being, a question about consumed extra doses of analgesics (painkillers), and the possibility to write free text messages to the care providers. Participants use a digital pen to fill in the diary and data is transmitted using the cell phone network to a server system. The server system includes possibilities for visualizing data and for sending text messages to care providers when symptoms increase.
What are the possible benefits and risks of participating?
Participants may benefit from a richer participation in their own care and an increased sense of security. Every piece of information stored in the information system is protected from unauthorized access. Participants using the IT system shall use traditional routines if the IT system fails.
Where is the study run from?
The study is run from Linköping University, with participating home healthcare clinics from Östergötland, Sörmland and Kalmar counties (Sweden).
When is the study starting and how long is it expected to run for?
February 2008 to December 2009
Who is funding the study?
1. VINNOVA, the Swedish Governmental Agency for Innovation Systems
2. Santa Anna IT Research Institute AB/Swedish ICT Research
Who is the main contact?
Dr Leili Lind
leili.lind@liu.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Leili Lind
ORCID ID
Contact details
IMT
Linköpings Universitet
Linköping
58185
Sweden
-
leili.lind@liu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
n/a
Study information
Scientific title
PallPen - IT support for home healthcare: reporting of symptoms and messages with a digital pen - a randomized controlled trial
Acronym
PallPen
Study hypothesis
The use of Information Technology (IT) in palliative home healthcare has the ability to reduce the time span of the patients assessed and reported symptoms until these reports were received by the professional caregiver.
Ethics approval
Regional Ethical Review Board in Linköping, Sweden, 20/06/2007, ref: M101-07
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Patients with end-stage cancer receiving advanced palliative home care
Intervention
One group receives an IT system to be used for symptom reporting while the other group uses traditional ways of symptom reporting.
The intervention consisted of a Symptom Diary form together with digital pen technology to capture symptom assessments in the home of the patient. The Symptom Diary included the assessment of pain intensity and well-being using 10 cm visual-analogue scales (VAS). Further, the diary included a question about consumed extra doses of analgesics and the possibility to write free text messages to the care providers. Participants in the intervention arm used a digital pen to fill in the diary and data was transmitted using the cell phone network to a server system. The server system included possibilities for visualizing data and for sending text messages to care providers when the symptom level increased.
Intervention type
Device
Phase
Drug names
Primary outcome measure
The time span of the patients assessed and reported symptoms until these reports were received by the professional caregiver
Secondary outcome measures
No secondary outcome measures
Overall trial start date
16/02/2008
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients assessing their pain to Visual Analogue Scale (VAS) 3 (VAS 1-10 cm) or higher, or well-being to VAS 4 or higher
2. Participants were required to be mentally clear
3. Swedish-speaking to the level of understanding the study form and to be able to perform symptom assessments
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Given that 220 assessments were needed and an estimation of patients using the system for on average 7 days x 2 assessments daily, the estimated number of participants was 16
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
16/02/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Sweden
Trial participating centre
Linköpings Universitet
Linköping
58185
Sweden
Sponsor information
Organisation
Department of Biomedical Engineering (Sweden)
Sponsor details
IMT
Linköpings Universitet
Linköping
58185
Sweden
-
daniel.karlsson@liu.se
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Vinnova (Sweden)
Alternative name(s)
Swedish Governmental Agency for Innovation Systems
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Sweden
Funder name
Santa Anna IT Research Institute AB/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
Basic results (scientific)
Publication list