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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

RHAPSODY-plus: Online Counseling for Family Caregivers of Patients With Young Onset Dementia

Clinicaltrials.gov identifier NCT03923517

Recruitment Status Completed

First Posted April 22, 2019

Last update posted September 17, 2019

Study Description

Brief 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. 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.

  • Condition or Disease:Frontotemporal Dementia
    Early Onset Alzheimer Disease
  • Intervention/Treatment: Device: RHAPSODY online program and MEET online sessions
  • Phase: N/A
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
  • Study Type: Interventional
  • Actual Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: This pilot study is a single-site study. One intervention group (no control group) Not randomised Open label
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: RHAPSODY-plus: Online Counseling for Family Caregivers of Patients With Young Onset Dementia
  • Actual Study Start Date: January 2018
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: May 2019
Arms and interventions
Arm Intervention/treatment
Experimental: YOD caregiver
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).
Device: RHAPSODY online program and MEET online sessions
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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).
  • Secondary Outcome Measures: 1. Feasibility [ Time Frame: 1 year ]
    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)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Contacts and Locations
Contacts
Locations

Germany, Bayern
Zentrum für kognitive Störungen, Psychiatrische Klinik und Poliklinik, Klinikum Rechts der Isar, TU München
München

Sponsors and Collaborators

Technische Universität München

University of Melbourne

Investigators

Principal Investigator: Janine Diehl-Schmid, Prof. Technische Universität München

More Information