RelativesNCT04638608
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 study testing EMBRACE (relatives) and EMBRACE (Health care providers) in people with Relatives and Health Care Providers, run by Danish Rehabilitation Centre for Neuromuscular Diseases at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Relatives, Health Care Providers, Cognitive Impairment
- What is being tested?
- EMBRACE (relatives) and EMBRACE (Health care providers)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2019to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Danish national Rehabilitation Center for neuromuscular diseases
Aarhus, 8000
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Relatives, Health Care Providers, Cognitive Impairment, Rehabilitation
- Being tested
- EMBRACE (relatives), EMBRACE (Health care providers)
- Keywords
- Relatives, informal carer, family carer, ALS/MND, Cognitive impairment, Palliative rehabilitation, Blended learning, Online support, telehealth, e-learning, Peer-support, Health care providers
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMBRACE (relatives)Other
Online support program for both relatives
EMBRACE (Health care providers)Other
Online support program for health care providers
| Study group | Role | What they receive |
|---|---|---|
| EMBRACE (Relatives) | Other | Feasibility test of a new palliative rehabilitation blended learning program for relatives of people with ALS/cognitive impairments Receives: 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 Receives: Other: EMBRACE (Health care providers) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping with ALS and cognitive impairments
Framework of Complex Intervention in Health: MRC-guidelines according to acceptability, implementation and integration
Measured: 0-4 month
Secondary outcomes (2)
Burden
The Zarit Burden Interview (ZBI-22) questionnaires at baseline (Pre and post intervention)
Measured: 0-4 month
Anxiety and Stress
Hospital Anxiety and Depression Scale (HADS) (Pre and post intervention)
Measured: 0-4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Nov 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RelativesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Rehabilitation Centre for Neuromuscular Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Klem Olesen, Danish Rehabilitation Centre for Neuromuscular Diseases
- Investigators
- Charlotte Handberg, senior researcher, Study chair, The National Rehabilitation Center for Neuromuscular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638608
- Sponsor's protocol ID
- DanishRebCND
- Status last verified
- Feb 2023
- First submitted
- 10 Nov 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38343431Olesen 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.
PubMed 35610609Olesen 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.
PubMed 35187490
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04638608
- Acronym / sponsor ID
- DanishRebCND
- Conditions
- Relatives, Health Care Providers, Cognitive Impairment, Rehabilitation
- Keywords
- Relatives, informal carer, family carer, ALS/MND, Cognitive impairment, Palliative rehabilitation, Blended learning, Online support, telehealth, e-learning, Peer-support, Health care providers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Danish Rehabilitation Centre for Neuromuscular DiseasesUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMBRACE (Relatives) | Other | Other: EMBRACE (relatives)Feasibility test of a new palliative rehabilitation blended learning program for relatives of people with ALS/cognitive impairments |
| EMBRACE (Health care providers) | Other | Other: EMBRACE (Health care providers)Feasibility test of a new palliative rehabilitation blended learning program health care providers helping people with ALS/cognitive impairments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMBRACE (relatives)Online support program for both relatives | Other | EMBRACE (Relatives) |
| EMBRACE (Health care providers)Online support program for health care providers | Other | EMBRACE (Health care providers) |
Primary outcome
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
2 secondary outcomes
Burden
Time frame: 0-4 month
Anxiety and Stress
Time frame: 0-4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 38343431Olesen 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.
- Derived from this study: PubMed 35610609Olesen 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.
- Derived from this study: PubMed 35187490Olesen 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.
- Individual participant dataSharing planned: No
Related trials for Relatives
Not yet recruiting
Full-Thickness Skin Graft Sizing and Scar Quality
Full-Thickness Skin Graft Reconstruction of Nasal and Auricular Surgical Defects
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
Active, not recruitingPhase 1
A Phase 1 Relative Bioavailability Study of a VX-581 Tablet Formulation
Cystic Fibrosis
RecruitingPhase 1
A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)
Psoriasis, Healthy
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Handberg, senior researcher study chair
The National Rehabilitation Center for Neuromuscular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMBRACE (relatives) and EMBRACE (Health care providers) in people with Relatives and Health Care Providers, run by Danish Rehabilitation Centre for Neuromuscular Diseases at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coping with ALS and cognitive impairments (time frame: 0-4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04638608, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.