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

Not Applicable

Completed

• Conditions: Relatives; Health Care Providers; Rehabilitation; Cognitive Impairment
• Interventions: Other: EMBRACE (relatives); Other: EMBRACE (Health care providers)

• Registration Number: NCT04638608
• Lead Sponsor: Danish Rehabilitation Centre for Neuromuscular Diseases

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EMBRACE (Relatives)	EMBRACE (relatives)	Feasibility test of a new palliative rehabilitation blended learning program for relatives of people with ALS/cognitive impairments
EMBRACE (Health care providers)	EMBRACE (Health care providers)	Feasibility test of a new palliative rehabilitation blended learning program health care providers helping people with ALS/cognitive impairments

Primary Outcome Measures

Name	Time	Method
Coping with ALS and cognitive impairments	0-4 month	Framework of Complex Intervention in Health: MRC-guidelines according to acceptability, implementation and integration

Secondary Outcome Measures

Name	Time	Method
Burden	0-4 month	The Zarit Burden Interview (ZBI-22) questionnaires at baseline (Pre and post intervention)
Anxiety and Stress	0-4 month	Hospital Anxiety and Depression Scale (HADS) (Pre and post intervention)

Trial Locations

Locations (1)

The Danish national Rehabilitation Center for neuromuscular diseases; 🇩🇰 Aarhus, Denmark