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

Cognitive Impairment Clinical Trial

Official title:

A Complex Intervention Study on a Palliative Rehabilitation Blended Learning Program to Support Relatives and Health Care Providers of People With ALS and FTD in Coping With Challenges

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638608
• Other study ID #: DanishRebCND
• Status: Completed
• Phase: N/A
• 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
• 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:

-

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Health Care Providers
• Rehabilitation
• Relatives

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