Telepalliation - Digital Platform for Patients in Palliation and Their Relatives

NCT04995848 | Unknown

• 1 other identifier: N-20200094
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer; Heart Failure; Chronic Obstructive Pulmonary Disease; Neurological Diseases

Keywords

Palliative care; Palliation; Platform; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes in medicine

  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

  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

  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)

  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

  Week 4

Study Arms (2)

Telepalliation group

EXPERIMENTAL

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

Conventional palliation program

NO INTERVENTION

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

Interventions

Telepalliation OTHER

Telepalliation platform Telepal.dk

Telepalliation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Palliative Team, South West Jutland Hospital

Esbjerg, Denmark

RECRUITING

Related Publications (2)

• Sigaard JVA, Joensen EDR, Birgisdottir UR, Spindler H, Dinesen B. Telepalliation creates a sense of security: A qualitative study of patients with cancer receiving palliative care. Palliat Med. 2025 Oct 7:2692163251364145. doi: 10.1177/02692163251364145. Online ahead of print.

  PMID: 41055129 DERIVED

• Sigaard JVA, Henneberg NC, Schacksen CS, Kronborg SH, Petrini L, Kidholm K, Birgisdottir UR, Spindler H, Dinesen B. A Digital Platform (Telepalliation) for Patients in Palliative Care and Their Relatives: Protocol for a Multimethod Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 2;13:e49946. doi: 10.2196/49946.

  PMID: 38564264 DERIVED

Related Links

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

MeSH Terms

Conditions

Neoplasms; Heart Failure; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Birthe Dinesen, MSc, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

• Jarl Voss Andersen Sigaard, MD

  Palliative Team, South West Jutland Hospital

  STUDY DIRECTOR

Central Study Contacts

Birthe Dinesen, MSc, PhD

CONTACT

+4520515944; bid@hst.aau.dk

Jarl Voss Andersen Sigaard, MD

CONTACT

Jarl.Sigaard@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Mixed method randomised control trial

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: August 9, 2021
• Study Start: May 26, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)