Telepalliation - Digital Platform for Patients in Palliation and Their Relatives

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

Detailed Description
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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.

Official Title
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Elepalliation - Digital Platform for Patienter i Palliation og Deres pårørende

Conditions
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Cancer, Heart Failure, Chronic Obstructive Pulmonary Disease, Neurological Diseases

Intervention / Treatment
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* Other: Telepalliation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Mixed method randomised control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telepalliation group<br>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 | Other: Telepalliation<br>* Telepalliation platform Telepal.dk<br>|
| No Intervention: Conventional palliation program<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals | Qualitative interviews | 12 months | 
| Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals | Observations | 12 months | 
| Health related quality of life | Measured by EQ-5D Health Questionnaire | week 1 and week 4 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care, Palliation, Platform, Quality of life