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

September 16, 2019 updated by: Janine Diehl-Schmid, Technical University of Munich
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • München, Bayern, Germany, 81675
        • Zentrum für kognitive Störungen, Psychiatrische Klinik und Poliklinik, Klinikum Rechts der Isar, TU München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Collaborators

University of Melbourne

Investigators

  • Principal Investigator: Janine Diehl-Schmid, Prof., Technical University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

May 30, 2019

Study Completion (Actual)

May 30, 2019

Study Registration Dates

First Submitted

April 12, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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