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
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Brief Summary
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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
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The projects concerns tree studies. 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. Developing a palliative rehabilitation blended learning program for relatives of people with ALS and cognitive impairments and for the health care providers. 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.

Official Title
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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

Conditions
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Relatives, Health Care Providers, Cognitive Impairment, Rehabilitation

Intervention / Treatment
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* Other: EMBRACE (relatives)
* Other: EMBRACE (Health care providers)


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALS/MND, Relatives, informal carer, family carer, Cognitive impairment, Palliative rehabilitation, Blended learning, Online support, telehealth, e-learning, Peer-support, Health care providers