Telepalliation - Digital Platform for Patients in Palliation and Their Relatives

July 18, 2023 updated by: Birthe Dinesen, Aalborg University

Elepalliation - Digital Platform for Patienter i Palliation og Deres pårørende

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Birthe Dinesen, MSc, PhD
  • Phone Number: +4520515944
  • Email: bid@hst.aau.dk

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telepalliation group

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:

  1. They stop being followed by the Palliative Team due to lack of symptoms

  2. 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
  3. Death of the patient
Other: Telepalliation
Telepalliation platform Telepal.dk
No Intervention: Conventional palliation program

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:

  1. They stop being followed by the Palliative Team due to lack of symptoms

  2. 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
  3. Death of the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Quality of life
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in medicine
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
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
Changes in feeling of security
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
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
Experiences of pain
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
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
Experience of pain (brief)
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
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
Experiences of patients on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
Time Frame: Week 4
Qualitative interviews
Week 4
Experiences of relatives on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
Time Frame: Week 4 and 3 months
Qualitative interviews
Week 4 and 3 months
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
Time Frame: 6 months and 12 months
Qualitative interviews
6 months and 12 months
Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
Time Frame: 12 months
Qualitative interviews
12 months
Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
Time Frame: 12 months
Observations
12 months
Health related quality of life
Time Frame: week 1 and week 4
Measured by EQ-5D Health Questionnaire
week 1 and week 4
Cost of healthcare services
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Collaborators

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

Investigators

  • Principal Investigator: Birthe Dinesen, MSc, PhD, Aalborg University
  • Study Director: Jarl Voss Andersen Sigaard, MD, Palliative Team, South West Jutland Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

May 26, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20200094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan for sharing protocol as we are applying for patent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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