Early Onset Alzheimer DiseaseRHAPSODY-plusNCT03923517
RHAPSODY-plus: Online Counseling for Family Caregivers of Patients With Young Onset Dementia
A study testing RHAPSODY online program and MEET online sessions in people with Early Onset Alzheimer Disease and Frontotemporal Dementia, run by Technical University of Munich at 1 site in Germany.
Trial summary
The RHAPSODY-plus project consists of two parts. In a first step carers of people with young onset dementia (YOD; onset before the age of 65) have the opportunity to use the RHAPSODY online program (Kurz et al., 2016) to inform themselves about different topics on young onset dementia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Onset Alzheimer Disease, Frontotemporal Dementia
- What is being tested?
- RHAPSODY online program and MEET online sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 30 May 2019
- 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
- informal carer of a person with YOD who has been diagnosed with either Frontal Temporal Dementia (FTD) or Alzheimer's Disease (AD) 12 months ago or less;
- the carer has face-to-face contact with the person with YOD at least twice a weak;
- the carer has a working computer and internet access in his home;
- the carer is available for the intervention duration of approximately eight weeks;
- the carer is fluent in German;
- signed consent form.
Who cannot join
- the carer has face-to-face contact with the person with YOD less than twice a week;
- the person with YOD the carer is caring for has a different dementia cause other than FTD or AD or the diagnosis is older than 12 months;
- the carer does not have a working computer and internet access at home or is not confident to use them;
- the carer is not available for the approximately eight week intervention duration;
- the carer is not fluent in German;
- the carer has a significant health problem or disability, which precludes him/her from participating in the study;
- no signed informed consent.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Zentrum für kognitive Störungen, Psychiatrische Klinik und Poliklinik, Klinikum Rechts der Isar, TU München
München, Bavaria, 81675
About this study
The RHAPSODY-plus project consists of two parts. In a first step carers of people with young onset dementia (YOD; onset before the age of 65) have the opportunity to use the RHAPSODY online program (Kurz et al., 2016) to inform themselves about different topics on young onset dementia. In a second step the participants will receive two individual counseling sessions via MEET (online videoconferencing) with a social worker and a psychologist. Goal is to investigate whether these counseling sessions have an additional benefit.
Read the detailed description
RHAPSODY-plus is a joint project of the Technische Universität München, Zentrum für kognitive Störungen and the Melbourne University. The project consists of two parts. In a first step carers of people with young onset dementia (YOD; onset before the age of 65) have the opportunity to use the RHAPSODY online program (Kurz et al., 2016) for four weeks. This e-learning program focuses on managing problem behaviors, dealing with role change, obtaining support, and looking after oneself. In a second step the participants will receive two individual counseling sessions via MEET (online videoconferencing). In a first session carers can talk with a social worker about individual problems concerning social, financial and legal issues. In a second session with a psychologist personal and emotional problems can be addressed. These two sessions are about 60 minutes. The study investigates whether these counseling sessions have an additional benefit. The primary aim is to determine whether the intervention is considered acceptable and useful by the participants. Secondary aim is to investigate whether the intervention is feasible. The sample size will be determined when data saturation is reached (no new themes emerge from the qualitative data at the final feedback session). From previous experiences with pilot studies using qualitative methods we expect this to be achieved with approximately 20 participants. This number of participants should also ensure that a diverse group of carers is participating in this pilot study (both genders; different age groups, types of relatives; diagnoses (both FTD and AD) for care recipients; environments (city versus rural); socioeconomic status; and carer stressors (carers with children, carers who hold a job, carers with different stressors, etc.).
- Being tested
- RHAPSODY online program and MEET online sessions
- Keywords
- Young onset dementia, caregiver, online intervention, online communication technology
- Medical subject headings
- Alzheimer Disease, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHAPSODY online program and MEET online sessionsDevice
internet-based information and skill-building program (RHAPSODY) specifically developed for family carers of care recipients with young onset dementia (Kurz, et al., 2016).
MEET is a software for online meetings.
| Study group | Role | What they receive |
|---|---|---|
| YOD caregiver | Experimental | The participants will be encouraged to use RHAPSODY for four weeks. After that they will have two individual MEET sessions with experts (social worker and psychologist). Receives: Device: RHAPSODY online program and MEET online sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and usefulness
The primary aim of this study is to determine whether the online-video conference-counseling is considered acceptable and useful by the family caregivers. This will be derived from the analysis of caregiver interviews (qualitative research methods).
Measured: 1 year
Secondary outcomes (1)
Feasibility
Secondary aim is to investigate whether the intervention is feasible for the caregivers.This will be derived from the analysis of caregiver interviews (qualitative research methods)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Jan 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Onset Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This pilot study is a single-site study. One intervention group (no control group) Not randomised Open label
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne
- Responsible party
- Principal investigator, Janine Diehl-Schmid, Technical University of Munich
- Investigators
- Janine Diehl-Schmid, Prof., Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923517
- Sponsor's protocol ID
- RP123
- Acronym
- RHAPSODY-plus
- Status last verified
- Sep 2019
- First submitted
- 12 Apr 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kurz A, Bakker C, Bohm M, Diehl-Schmid J, Dubois B, Ferreira C, Gage H, Graff C, Hergueta T, Jansen S, Jones B, Komar A, de Mendonca A, Metcalfe A, Milecka K, Millenaar J, Orrung Wallin A, Oyebode J, Schneider-Schelte H, Saxl S, de Vugt M. RHAPSODY - Internet-based support for caregivers of people with young onset dementia: program design and methods of a pilot study. Int Psychogeriatr. 2016 Dec;28(12):2091-2099. doi: 10.1017/S1041610216001186. Epub 2016 Aug 30.
PubMed 27572272Lautenschlager NT, Diehl-Schmid J, Loi SM, Mayer J, Tensil M, Kurz AF. Modern technology to support carers of care recipients with dementia or functional mental illness: promising progress, but a long road ahead. Int Psychogeriatr. 2017 Dec;29(12):1933-1935. doi: 10.1017/S1041610217002150.
PubMed 29130870
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RHAPSODY-plus: Online Counseling for Family Caregivers of Patients With Young Onset Dementia
- ClinicalTrials.gov ID
- NCT03923517
- Acronym / sponsor ID
- RHAPSODY-plus / RP123
- Keywords
- Young onset dementia, caregiver, online intervention, online communication technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- University of Melbourne
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 22 Apr 2019 (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.
The RHAPSODY-plus project consists of two parts. In a first step carers of people with young onset dementia (YOD; onset before the age of 65) have the opportunity to use the RHAPSODY online program (Kurz et al., 2016) to inform themselves about different topics on young onset dementia. In a second step the participants will receive two individual counseling sessions via MEET (online videoconferencing) with a social worker and a psychologist. Goal is to investigate whether these counseling sessions have an additional benefit.
Detailed description
RHAPSODY-plus is a joint project of the Technische Universität München, Zentrum für kognitive Störungen and the Melbourne University. The project consists of two parts. In a first step carers of people with young onset dementia (YOD; onset before the age of 65) have the opportunity to use the RHAPSODY online program (Kurz et al., 2016) for four weeks. This e-learning program focuses on managing problem behaviors, dealing with role change, obtaining support, and looking after oneself. In a second step the participants will receive two individual counseling sessions via MEET (online videoconferencing). In a first session carers can talk with a social worker about individual problems concerning social, financial and legal issues. In a second session with a psychologist personal and emotional problems can be addressed. These two sessions are about 60 minutes. The study investigates whether these counseling sessions have an additional benefit. The primary aim is to determine whether the intervention is considered acceptable and useful by the participants. Secondary aim is to investigate whether the intervention is feasible. The sample size will be determined when data saturation is reached (no new themes emerge from the qualitative data at the final feedback session). From previous experiences with pilot studies using qualitative methods we expect this to be achieved with approximately 20 participants. This number of participants should also ensure that a diverse group of carers is participating in this pilot study (both genders; different age groups, types of relatives; diagnoses (both FTD and AD) for care recipients; environments (city versus rural); socioeconomic status; and carer stressors (carers with children, carers who hold a job, carers with different stressors, etc.).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This pilot study is a single-site study. One intervention group (no control group) Not randomised Open label
| Arm | Type | Receives |
|---|---|---|
| YOD caregiver | Experimental | Device: RHAPSODY online program and MEET online sessionsThe participants will be encouraged to use RHAPSODY for four weeks. After that they will have two individual MEET sessions with experts (social worker and psychologist). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- informal carer of a person with YOD who has been diagnosed with either Frontal Temporal Dementia (FTD) or Alzheimer's Disease (AD) 12 months ago or less;
- the carer has face-to-face contact with the person with YOD at least twice a weak;
- the carer has a working computer and internet access in his home;
- the carer is available for the intervention duration of approximately eight weeks;
- the carer is fluent in German;
Key exclusion criteria (7 listed)
- the carer has face-to-face contact with the person with YOD less than twice a week;
- the person with YOD the carer is caring for has a different dementia cause other than FTD or AD or the diagnosis is older than 12 months;
- the carer does not have a working computer and internet access at home or is not confident to use them;
- the carer is not available for the approximately eight week intervention duration;
- the carer is not fluent in German;
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 |
|---|---|---|
| RHAPSODY online program and MEET online sessionsinternet-based information and skill-building program (RHAPSODY) specifically developed for family carers of care recipients with young onset dementia (Kurz, et al., 2016). MEET is a software for online meetings. | Device | YOD caregiver |
Primary outcome
Acceptability and usefulness
Time frame: 1 year
The primary aim of this study is to determine whether the online-video conference-counseling is considered acceptable and useful by the family caregivers. This will be derived from the analysis of caregiver interviews (qualitative research methods).
1 secondary outcome
Feasibility
Time frame: 1 year
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 17 Sep 2019.
- Background: PubMed 27572272Kurz A, Bakker C, Bohm M, Diehl-Schmid J, Dubois B, Ferreira C, Gage H, Graff C, Hergueta T, Jansen S, Jones B, Komar A, de Mendonca A, Metcalfe A, Milecka K, Millenaar J, Orrung Wallin A, Oyebode J, Schneider-Schelte H, Saxl S, de Vugt M. RHAPSODY - Internet-based support for caregivers of people with young onset dementia: program design and methods of a pilot study. Int Psychogeriatr. 2016 Dec;28(12):2091-2099. doi: 10.1017/S1041610216001186. Epub 2016 Aug 30.
- Background: PubMed 29130870Lautenschlager NT, Diehl-Schmid J, Loi SM, Mayer J, Tensil M, Kurz AF. Modern technology to support carers of care recipients with dementia or functional mental illness: promising progress, but a long road ahead. Int Psychogeriatr. 2017 Dec;29(12):1933-1935. doi: 10.1017/S1041610217002150.
- Individual participant dataSharing planned: Undecided
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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.
Janine Diehl-Schmid, Prof. principal investigator
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RHAPSODY online program and MEET online sessions in people with Early Onset Alzheimer Disease and Frontotemporal Dementia, run by Technical University of Munich at 1 site in Germany.
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 6 inclusion and 7 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 17 Sep 2019. 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 Germany. 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?
Acceptability and usefulness (time frame: 1 year). 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 NCT03923517, which also lists 2 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 17 Sep 2019.