Telepalliation - Digital Platform for Patients in Palliation and Their Relatives

Cancer Clinical Trial

Official title:

Elepalliation - Digital Platform for Patienter i Palliation og Deres pårørende

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04995848
• Other study ID #: N-20200094
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: Aalborg University
• Contact: Birthe Dinesen, MSc, PhD
• Phone: +4520515944
• Email: bid[@]hst.aau.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project has focus on patients in palliation testing a digital platform TelePal.dk.

Description:

The aim of the RCT study is to:

• Test, implement, and evaluate a telepalliation program for patients receiving palliative care (cancer, heart failure (HF), COPD, and motor neuron disease) from a clinical, psychosocial, inter-organizational, and health economic perspective.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years

• Live in Esbjerg, Varde, Billund, Fanø or Vejen Municipality

• Cancer, heart failure, chronic obstructive pulmonary disease (COPD), and motor neuron disease (neurological diseases) referred to the Palliation Team at Southwest Jutland Hospital

• Basic computer skills or a relative who has basic computer skills

Exclusion Criteria:

• Delirium at enrolment based on CAM score

• Active psychiatric history (as noted in the medical record) other than depression or anxiety related to the main diagnosis referred to palliative care

• Lack of ability to cooperate

Related Conditions & MeSH terms

• Cancer
• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Lung Diseases, Obstructive
• Nervous System Diseases
• Neurological Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Telepalliation
Telepalliation platform Telepal.dk

Locations

Country	Name	City	State
Denmark	Palliative Team, South West Jutland Hospital	ESbjerg

Sponsors (5)

Lead Sponsor	Collaborator
Aalborg University	Center for Innovative Medical Technologies (CIMT), Odense University Hospital, Danish Cancer Society, Laboratory of Welfare Technology, Department of Health Science and Technology, Aalborg University, Palliative Team,Hospital of South West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Quality of life	Measured by the European Organization for Research and Treatment of Cancer, questionnaire regarding quality of life in palliative cancer care patients (EORTC QLQ-C15-PAL).	At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Secondary	Changes in medicine	Information on medicine for both groups will be collected at enrolment and every week from the electronic patient record (EPR). Changes in medicine over time will be analyzed.	At enrolment and week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Secondary	Changes in feeling of security	Measured on a likert scale	At baseline, twice every week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Secondary	Experiences of pain	Numerical Rating Scale (NRS)	At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Secondary	Experience of pain (brief)	Brief Pain Inventory, short form (BPI-sf)	At baseline, week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26
Secondary	Experiences of patients on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program	Qualitative interviews	Week 4
Secondary	Experiences of relatives on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program	Qualitative interviews	Week 4 and 3 months
Secondary	Experiences of health care professionals on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program	Qualitative interviews	6 months and 12 months
Secondary	Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals	Qualitative interviews	12 months
Secondary	Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals	Observations	12 months
Secondary	Health related quality of life	Measured by EQ-5D Health Questionnaire	week 1 and week 4
Secondary	Cost of healthcare services	Cost-effectiveness analysis ((number of phone/video calls, equipment, driving, personal use in palliative care (video and home visits), visits to general practitioner and outpatient clinic, hospitalizations, readmissions and length of stay, visits from palliative team))	24 months

External Links

•   Read more about the Laboratory for Welfare Technology - telehealth and telerehabilitation, Aalborg University