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

February 14, 2023 updated by: Lene Klem Olesen, Danish Rehabilitation Centre for Neuromuscular Diseases

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • The Danish national Rehabilitation Center for neuromuscular diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EMBRACE (Relatives)
Feasibility test of a new palliative rehabilitation blended learning program for relatives of people with ALS/cognitive impairments
Other: EMBRACE (relatives)
Online support program for both relatives
Other: EMBRACE (Health care providers)
Feasibility test of a new palliative rehabilitation blended learning program health care providers helping people with ALS/cognitive impairments
Other: EMBRACE (Health care providers)
Online support program for health care providers

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burden
Time Frame: 0-4 month
The Zarit Burden Interview (ZBI-22) questionnaires at baseline (Pre and post intervention)
0-4 month
Anxiety and Stress
Time Frame: 0-4 month
Hospital Anxiety and Depression Scale (HADS) (Pre and post intervention)
0-4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Rehabilitation Centre for Neuromuscular Diseases

Investigators

  • Study Chair: Charlotte Handberg, senior researcher, The National Rehabilitation Center for Neuromuscular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DanishRebCND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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