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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04995848
Other study ID # N-20200094
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 26, 2021
Est. completion date August 1, 2024

Study information

Verified date July 2023
Source Aalborg University
Contact Birthe Dinesen, MSc, PhD
Phone +4520515944
Email bid@hst.aau.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 182
Est. completion date August 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Telepalliation
Telepalliation platform Telepal.dk

Locations

Country Name City State
Denmark Palliative Team, South West Jutland Hospital ESbjerg

Sponsors (5)

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

Country where clinical trial is conducted

Denmark, 

Outcome

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