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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04638608
Enrollment
28
Registered
2020-11-20
Start date
2019-11-01
Completion date
2022-10-31
Last updated
2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Health Care Providers, Rehabilitation, Relatives

Keywords

Relatives, informal carer, family carer, ALS/MND, Cognitive impairment, Palliative rehabilitation, Blended learning, Online support, telehealth, e-learning, Peer-support, Health care providers

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.

Interventions

OTHEREMBRACE (relatives)

Online support program for both relatives

OTHEREMBRACE (Health care providers)

Online support program for health care providers

Sponsors

Danish Rehabilitation Centre for Neuromuscular Diseases
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Coping with ALS and cognitive impairments0-4 monthFramework of Complex Intervention in Health: MRC-guidelines according to acceptability, implementation and integration

Secondary

MeasureTime frameDescription
Burden0-4 monthThe Zarit Burden Interview (ZBI-22) questionnaires at baseline (Pre and post intervention)
Anxiety and Stress0-4 monthHospital Anxiety and Depression Scale (HADS) (Pre and post intervention)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026