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出境医 / 临床实验 / RHAPSODY-plus: Online Counseling for Family Caregivers of Patients With Young Onset Dementia (RHAPSODY-plus)

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

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 Intervention/treatment Phase
Early Onset Alzheimer Disease Frontotemporal Dementia Device: RHAPSODY online program and MEET online sessions Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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 1, 2018
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : May 30, 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
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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

Locations
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Germany
Zentrum für kognitive Störungen, Psychiatrische Klinik und Poliklinik, Klinikum Rechts der Isar, TU München
München, Bayern, Germany, 81675
Sponsors and Collaborators
Technische Universität München
University of Melbourne
Investigators
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Principal Investigator: Janine Diehl-Schmid, Prof. Technische Universität München
Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE January 1, 2018
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019) 		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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019) 		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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RHAPSODY-plus: Online Counseling for Family Caregivers of Patients With Young Onset Dementia
Official Title  ICMJE RHAPSODY-plus: Online Counseling for Family Caregivers of Patients With Young Onset Dementia
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • Early Onset Alzheimer Disease
  • Frontotemporal Dementia
Intervention  ICMJE 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.
Study Arms  ICMJE 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).
Intervention: Device: RHAPSODY online program and MEET online sessions
Publications *
  • Kurz A, Bakker C, Böhm M, Diehl-Schmid J, Dubois B, Ferreira C, Gage H, Graff C, Hergueta T, Jansen S, Jones B, Komar A, de Mendonça 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. Epub 2016 Aug 30.
  • Lautenschlager 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 30, 2019
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923517
Other Study ID Numbers  ICMJE RP123
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Janine Diehl-Schmid, Technische Universität München
Study Sponsor  ICMJE Technische Universität München
Collaborators  ICMJE University of Melbourne
Investigators  ICMJE
Principal Investigator: Janine Diehl-Schmid, Prof. Technische Universität München
PRS Account Technische Universität München
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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