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Telepalliation - Digital Platform for Patients in Palliation and Their Relatives

Primary Purpose

Cancer, Heart Failure, Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telepalliation
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Palliative care, Palliation, Platform, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Palliative Team, South West Jutland HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telepalliation group

Conventional palliation program

Arm Description

The intervention group will participate in the telepalliation program. The patients will lent a tablet during the RCT study to access the TelePal.dk platform an video consultations. The patients will participate from the time they are referred to palliative care, and are enrolled in the telepalliation program for up to six months or until: They stop being followed by the Palliative Team due to lack of symptoms They are diagnosed with delirium based upon clinical guidelines and the Confusion Assessment Method (CAM). The assessment of delirium will be done by either: The project nurse or the clinical responsible doctor at the patients' home OR A district nurse under video supervision by the project nurse or the clinical responsible doctor Death of the patient

The control group will follow a conventional palliation program. The patients will participate from the time they are referred to palliative care, and are enrolled in the telepalliation program for up to six months or until: They stop being followed by the Palliative Team due to lack of symptoms They are diagnosed with delirium based upon clinical guidelines and the Confusion Assessment Method (CAM). The assessment of delirium will be done by either: The project nurse or the clinical responsible doctor at the patients' home OR A district nurse under video supervision by the project nurse or the clinical responsible doctor Death of the patient

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Changes in feeling of security
Measured on a likert scale
Experiences of pain
Numerical Rating Scale (NRS)
Experience of pain (brief)
Brief Pain Inventory, short form (BPI-sf)
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
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
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
Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
Qualitative interviews
Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
Observations
Health related quality of life
Measured by EQ-5D Health Questionnaire
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))

Full Information

First Posted
May 26, 2021
Last Updated
July 18, 2023
Sponsor
Aalborg University
Collaborators
Palliative Team,Hospital of South West Jutland, Center for Innovative Medical Technologies (CIMT), Odense University Hospital, Danish Cancer Society, Laboratory of Welfare Technology, Department of Health Science and Technology, Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT04995848
Brief Title
Telepalliation - Digital Platform for Patients in Palliation and Their Relatives
Official Title
Elepalliation - Digital Platform for Patienter i Palliation og Deres pårørende
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Palliative Team,Hospital of South West Jutland, Center for Innovative Medical Technologies (CIMT), Odense University Hospital, Danish Cancer Society, Laboratory of Welfare Technology, Department of Health Science and Technology, Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Heart Failure, Chronic Obstructive Pulmonary Disease, Neurological Diseases
Keywords
Palliative care, Palliation, Platform, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Mixed method randomised control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telepalliation group
Arm Type
Experimental
Arm Description
The intervention group will participate in the telepalliation program. The patients will lent a tablet during the RCT study to access the TelePal.dk platform an video consultations. The patients will participate from the time they are referred to palliative care, and are enrolled in the telepalliation program for up to six months or until: They stop being followed by the Palliative Team due to lack of symptoms They are diagnosed with delirium based upon clinical guidelines and the Confusion Assessment Method (CAM). The assessment of delirium will be done by either: The project nurse or the clinical responsible doctor at the patients' home OR A district nurse under video supervision by the project nurse or the clinical responsible doctor Death of the patient
Arm Title
Conventional palliation program
Arm Type
No Intervention
Arm Description
The control group will follow a conventional palliation program. The patients will participate from the time they are referred to palliative care, and are enrolled in the telepalliation program for up to six months or until: They stop being followed by the Palliative Team due to lack of symptoms They are diagnosed with delirium based upon clinical guidelines and the Confusion Assessment Method (CAM). The assessment of delirium will be done by either: The project nurse or the clinical responsible doctor at the patients' home OR A district nurse under video supervision by the project nurse or the clinical responsible doctor Death of the patient
Intervention Type
Other
Intervention Name(s)
Telepalliation
Intervention Description
Telepalliation platform Telepal.dk
Primary Outcome Measure Information:
Title
Changes in Quality of life
Description
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).
Time Frame
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 Outcome Measure Information:
Title
Changes in medicine
Description
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.
Time Frame
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
Title
Changes in feeling of security
Description
Measured on a likert scale
Time Frame
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
Title
Experiences of pain
Description
Numerical Rating Scale (NRS)
Time Frame
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
Title
Experience of pain (brief)
Description
Brief Pain Inventory, short form (BPI-sf)
Time Frame
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
Title
Experiences of patients on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
Description
Qualitative interviews
Time Frame
Week 4
Title
Experiences of relatives on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
Description
Qualitative interviews
Time Frame
Week 4 and 3 months
Title
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
Description
Qualitative interviews
Time Frame
6 months and 12 months
Title
Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
Description
Qualitative interviews
Time Frame
12 months
Title
Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
Description
Observations
Time Frame
12 months
Title
Health related quality of life
Description
Measured by EQ-5D Health Questionnaire
Time Frame
week 1 and week 4
Title
Cost of healthcare services
Description
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))
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birthe Dinesen, MSc, PhD
Phone
+4520515944
Email
bid@hst.aau.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jarl Voss Andersen Sigaard, MD
Email
Jarl.Sigaard@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birthe Dinesen, MSc, PhD
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jarl Voss Andersen Sigaard, MD
Organizational Affiliation
Palliative Team, South West Jutland Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Palliative Team, South West Jutland Hospital
City
ESbjerg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarl Sigaard
Email
jarl.Sigaard@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan for sharing protocol as we are applying for patent.
Links:
URL
http://www.labwelfaretech.com/en/
Description
Read more about the Laboratory for Welfare Technology - telehealth and telerehabilitation, Aalborg University

Learn more about this trial

Telepalliation - Digital Platform for Patients in Palliation and Their Relatives

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