Elepalliation - Digital Platform for Patienter i Palliation og Deres pårørende
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- Changes in Quality of life
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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:
- 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: Telepalliation (Other)
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:
- 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 Outcomes
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).
Secondary Outcomes
- Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals(12 months)
- Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals(12 months)
- 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)
- 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(6 months and 12 months)
- Health related quality of life(week 1 and week 4)
- Cost of healthcare services(24 months)
- 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)
- 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)
- Experiences of relatives on the actual use of the TelePal.dk platform and their experiences of being a part of a telepalliation program(Week 4 and 3 months)
Investigators
Birthe Dinesen
Professor
Aalborg University