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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04638608
Other study ID # DanishRebCND
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date October 31, 2022

Study information

Verified date February 2023
Source Danish Rehabilitation Centre for Neuromuscular Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A complex intervention study on a palliative rehabilitation blended learning program to support relatives and health care providers of people with ALS and cognitive impairments in coping with challenges.


Description:

The projects concerns tree studies. 1. Identifying experience-based evidence of relative of deceased people with ALS/cognitive impairments and health care providers (working with these persons) and develop an intervention program. 2. Developing a palliative rehabilitation blended learning program for relatives of people with ALS and cognitive impairments and for the health care providers. 3. Feasibility testing of the two palliative rehabilitation blended learning programs for relatives and health care providers. Though online palliative rehabilitation the intervention aims to support both relatives of people with ALS/cognitive impairments and health care providers in coping with challenges related to the diseases. The intervention consists of blended learning through online videos and virtual group meetings, where peer-support play an essential role. The videos consists of a psycho education, mindfulness based stress reduction, relationship changes, intimacy, sorrow and grief, control management, planning the future, how to communicate, hope, creating memories, external support offers. Besides the videos and group meetings, the relatives are given the possibility to make Ecomaps and diary reflections.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date October 31, 2022
Est. primary completion date October 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Relatives - relatives (spouse or partner) living with a person with ALS and cognitive impairments (rated on the ALS-FTD-Q by the relative, cut-off >22) Able to talk and understand proficient danish referred to the national rehabilitation center for neuromuscular diseases and have had a visit from an als-consultant Exclusion Criteria: -

Study Design


Intervention

Other:
EMBRACE (relatives)
Online support program for both relatives
EMBRACE (Health care providers)
Online support program for health care providers

Locations

Country Name City State
Denmark The Danish national Rehabilitation Center for neuromuscular diseases Aarhus

Sponsors (1)

Lead Sponsor Collaborator
Danish Rehabilitation Centre for Neuromuscular Diseases

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coping with ALS and cognitive impairments Framework of Complex Intervention in Health: MRC-guidelines according to acceptability, implementation and integration 0-4 month
Secondary Burden The Zarit Burden Interview (ZBI-22) questionnaires at baseline (Pre and post intervention) 0-4 month
Secondary Anxiety and Stress Hospital Anxiety and Depression Scale (HADS) (Pre and post intervention) 0-4 month
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