Telepalliation - Digital Platform for Patients in Palliation and Their Relatives

Sponsor
Aalborg University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04995848
Collaborator
Palliative Team,Hospital of South West Jutland (Other), Center for Innovative Medical Technologies (CIMT), Odense University Hospital (Other), Danish Cancer Society (Other), Laboratory of Welfare Technology, Department of Health Science and Technology, Aalborg University (Other)
182
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2
37.2
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Telepalliation
N/A

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
Anticipated Enrollment :
182 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Mixed method randomised control trialMixed method randomised control trial
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Elepalliation - Digital Platform for Patienter i Palliation og Deres pårørende
Actual Study Start Date :
May 26, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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: 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
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: 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

Outcome Measures

Primary Outcome Measures

  1. Changes in Quality of life [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 Outcome Measures

  1. 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]

    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.

  2. 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]

    Measured on a likert scale

  3. 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]

    Numerical Rating Scale (NRS)

  4. 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]

    Brief Pain Inventory, short form (BPI-sf)

  5. 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]

    Qualitative interviews

  6. 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]

    Qualitative interviews

  7. 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]

    Qualitative interviews

  8. Perceptions on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals [12 months]

    Qualitative interviews

  9. Observations on usability of a cross-sector communication platform and telerehabilitation program by patients, relatives and health care professionals [12 months]

    Observations

  10. Health related quality of life [week 1 and week 4]

    Measured by EQ-5D Health Questionnaire

  11. Cost of healthcare services [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))

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Palliative Team, South West Jutland Hospital ESbjerg Denmark

Sponsors and Collaborators

  • Aalborg University
  • Palliative Team,Hospital of South West Jutland
  • Center for Innovative Medical Technologies (CIMT), Odense University Hospital
  • Danish Cancer Society
  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Birthe Dinesen, Professor, Aalborg University
ClinicalTrials.gov Identifier:
NCT04995848
Other Study ID Numbers:
  • N-20200094
First Posted:
Aug 9, 2021
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Birthe Dinesen, Professor, Aalborg University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2021