PallPen - IT support for home healthcare: reporting of symptoms and messages with a digital pen
| ISRCTN | ISRCTN09750271 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09750271 |
| Secondary identifying numbers | n/a |
- Submission date
- 23/04/2012
- Registration date
- 16/05/2012
- Last edited
- 12/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
IMT
Linköpings Universitet
Linköping
58185
Sweden
| leili.lind@liu.se |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | PallPen - IT support for home healthcare: reporting of symptoms and messages with a digital pen - a randomized controlled trial |
| Study acronym | PallPen |
| Study objectives | 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(s) | Regional Ethical Review Board in Linköping, Sweden, 20/06/2007, ref: M101-07 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 16/02/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 16/02/2008 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Sweden
Study participating centre
58185
Sweden
Sponsor information
University/education
IMT
Linköpings Universitet
Linköping
58185
Sweden
| daniel.karlsson@liu.se | |
| Website | http://www.imt.liu.se/ |
"ROR" |
https://ror.org/05ynxx418 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Swedish Governmental Agency for Innovation Systems
- Location
- Sweden
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
12/06/2017: Plain English summary added.
