NCT04638608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 10, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

November 10, 2020

Last Update Submit

February 14, 2023

Conditions

RelativesHealth Care ProvidersCognitive ImpairmentRehabilitation

Keywords

Relatives, informal carer, family carerALS/MNDCognitive impairmentPalliative rehabilitationBlended learningOnline support, telehealth, e-learningPeer-supportHealth care providers

Outcome Measures

Primary Outcomes (1)

  • Coping with ALS and cognitive impairments

    Framework of Complex Intervention in Health: MRC-guidelines according to acceptability, implementation and integration

    0-4 month

Secondary Outcomes (2)

  • Burden

    0-4 month

  • Anxiety and Stress

    0-4 month

Study Arms (2)

EMBRACE (Relatives)

OTHER

Feasibility test of a new palliative rehabilitation blended learning program for relatives of people with ALS/cognitive impairments

Other: EMBRACE (relatives)

EMBRACE (Health care providers)

OTHER

Feasibility test of a new palliative rehabilitation blended learning program health care providers helping people with ALS/cognitive impairments

Other: EMBRACE (Health care providers)

Interventions

EMBRACE (relatives)OTHER

Online support program for both relatives

EMBRACE (Relatives)
EMBRACE (Health care providers)OTHER

Online support program for health care providers

EMBRACE (Health care providers)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Danish national Rehabilitation Center for neuromuscular diseases

Aarhus, 8000, Denmark

Location

Related Publications (3)

  • Olesen LK, la Cour K, Nimmon L, With H, Handberg C. Experiences of an Online Palliative Rehabilitation Programme for Spousal Caregivers of People With Amyotrophic Lateral Sclerosis and Cognitive and/or Behavioural Impairments: A Qualitative Interpretive Study. Adv Rehabil Sci Pract. 2024 Feb 9;13:27536351241227860. doi: 10.1177/27536351241227860. eCollection 2024 Jan-Dec.

    PMID: 38343431DERIVED

  • Olesen LK, la Cour K, With H, Mahoney AF, Handberg C. A cross-sectional evaluation of acceptability of an online palliative rehabilitation program for family caregivers of people with amyotrophic lateral sclerosis and cognitive and behavioral impairments. BMC Health Serv Res. 2022 May 24;22(1):697. doi: 10.1186/s12913-022-07986-4.

    PMID: 35610609DERIVED

  • Olesen LK, la Cour K, With H, Handberg C. Reflections of family caregivers and health professionals on the everyday challenges of caring for persons with amyotrophic lateral sclerosis and cognitive impairments: a qualitative study. Palliat Care Soc Pract. 2022 Feb 15;16:26323524221077702. doi: 10.1177/26323524221077702. eCollection 2022.

    PMID: 35187490DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

  • Charlotte Handberg, senior researcher

    The National Rehabilitation Center for Neuromuscular Diseases

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Occupational Therapist, MA in Educational psychology

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 20, 2020

Study Start

November 1, 2019

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)