Clinical trial NCT04995848: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Heart Failure
Chronic Obstructive Pulmonary Disease
Neurological Diseases
Keywords: Palliative care
Palliation
Platform
Quality of life
Lead sponsor: Aalborg University
Sponsor class: OTHER
Collaborators: name: Palliative Team,Hospital of South West Jutland
name: Center for Innovative Medical Technologies (CIMT), Odense University Hospital
name: Danish Cancer Society
name: Laboratory of Welfare Technology, Department of Health Science and Technology, Aalborg University
First posted: 2021-08-09
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Mixed method randomised control trial
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Changes in Quality of life
timeFrame: 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:
measure: Changes in medicine
timeFrame: 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
measure: Changes in feeling of security
timeFrame: 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
measure: Experiences of pain
timeFrame: 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
measure: Experience of pain (brief)
timeFrame: 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
measure: Experiences of patients on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
timeFrame: Week 4
measure: Experiences of relatives on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program
timeFrame: Week 4 and 3 months
measure: 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
timeFrame: 6 months and 12 months
measure: Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
timeFrame: 12 months
measure: Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals
timeFrame: 12 months
measure: Health related quality of life
timeFrame: week 1 and week 4
measure: Cost of healthcare services
timeFrame: 24 months
Other outcomes:
Locations:
city: ESbjerg
country: Denmark
facility: Palliative Team, South West Jutland Hospital
Study officials:
affiliation: Aalborg University
name: Birthe Dinesen, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palliative Team, South West Jutland Hospital
name: Jarl Voss Andersen Sigaard, MD
role: STUDY_DIRECTOR
References: