Intervention Study to Improve Life and Care for People With Dementia and Their Caregivers in Primary Care (DelpHi)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2011 by German Center for Neurodegenerative Diseases (DZNE)
Sponsor:
Collaborator:
University Medicine Greifswald
Information provided by:
German Center for Neurodegenerative Diseases (DZNE)
ClinicalTrials.gov Identifier:
NCT01401582
First received: July 18, 2011
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

Caring for people with dementia and treating them is a major challenge for the health care system in Germany. Among the challenges for population-based health care research are (a) identification and early recognition, (b) multimorbidity and (c) the integration of persons with dementia into the health care system. One setting which is identified to meet the challenges is the primary care setting and there especially the general physician. There have been a few interventional studies, which have been restricted to selective samples and have been conducted in inpatient settings.

The purpose of this study is to test the efficacy of implementing a subsidiary support system for persons with dementia living at home. This subsidiary support system is initiated by a Dementia Care Manager (DCM), a nurse with dementia-specific advanced training. The main goals are to improve quality of life and health care of the person with dementia and reduce caregiver´s burden.

The study is a general physician based cluster-randomised controlled intervention trial. A population based sample of general physicians will be asked to participate in a systematic screening trial to identify people with dementia in primary care in Mecklenburg Western Pommerania, a federal state in Germany. Upon identification the people will be asked to participate in the DelpHi-MV study and after having given written informed consent will then be assigned to an intervention and a control group. Identification of people with dementia will be achieved by a short screening questionnaire in the physician's office. An extended in-depth data assessment will be conducted after inclusion into the study and then annually to measure the course of the people's health. Data assessment will be done at the people's homes.

People assigned to the intervention group will receive an intervention provided by "Dementia Care Manager". The Dementia Care Manager is a specialised nurse that is going into the person's home to manage the care of dementia as well as caring for the person's relative/ or carer.


Condition Intervention
Dementia
Other: Provision of a "Dementia Care Manager"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Dementia: Life- and Personcentered Help in Germany

Resource links provided by NLM:


Further study details as provided by German Center for Neurodegenerative Diseases (DZNE):

Primary Outcome Measures:
  • change in quality of life [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]
    The Quality of Life in Alzheimer's Disease (Qol-AD; Logsdon et al. 2002) will be used

  • change in caregiver burden [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]
    The Berliner Inventar zur Angehörigenbelastung (BIZA-D; Zank et al. 2006) will be used

  • change in behavioral and psychological symptoms of dementia [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]
    Neuropsychiatric Inventory (NPI; Cummings 1997)

  • change in medical treatment with antidementia drugs [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]
    medication will be systematically reviewed

  • reduction of potential inapropriate medication (PIM) [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]
    measured by frequency of intake of anti-dementia drugs and frequency of PIM according to the PRISCUS criteria


Secondary Outcome Measures:
  • person with dementia: change in activities of daily living [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]
    The Bayer ADL (Erzigkeit et al. 2001) will be used to measure activities of daily living

  • person with dementia: change in cognitive status [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]
    The CERAD-test battery (Monsch, 1998) will be used to measure cognitive functioning in several domains

  • person with dementia: change in social support [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]
    The F-SozU (Fydrich et al. 2007) will be used to assess social support in several domains

  • person with dementia and caregiver: change in health status [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]

    Several instruments will be used to assess the health of the person with dementia:

    the GP records the Fragebogen zum SF12- health survey (SF-12, Bullinger et al. 1998) the standardized assessment of elderly in primary care (STEP; Sandholzer et al. 2004) the Brief Symptom Inventory (BSI; Derogatis et al. 1983) the Patient´s health questionnaire (PHQ-D; Löwe et al. 2002, Spitzer et al. 1999)


  • person with dementia: change in utilization of health care resources [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]

    frequency of utilisation of

    1. general physicians and physicians of other specialties
    2. out-patient treatments
    3. in-patient treatments
    4. hospitalisations
    5. institutionalisation
    6. therapeutic appliances

    standardised assessment with the Resource Utilization in Dementia (RUD, Wimo et al. 1998).


  • person with dementia: change in medication [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ] [ Designated as safety issue: No ]
    The DCM will conduct an IT-supported home medication review (Fiss et al., 2010) at the patients home with subsequent medication management by the local pharmacy regarding frequency of drug related problems, intake of PIM, clinically relevant drug-drug interaction, adherence, utilisation of adherence supporting activities (medication plan, drug dispenser, support by care service, reduction of the number of drugs taken


Estimated Enrollment: 1000
Study Start Date: September 2011
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: care as usual
care as usual, no intervention, just observation of natural change/ trajectories over time
Experimental: Implementation of Dementia Care Manager
Subjects in this arm will be provided with a specialised "Dementia Care Manager" to be included in a subsidiary support system
Other: Provision of a "Dementia Care Manager"
Home-visits of trained "Dementia Care Manager (DCM)" at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.
Other Names:
  • Dementia Care Manager
  • Care Management
  • counselling
  • supporting caregivers

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 70+ years
  • must be living at home
  • screening positive (DEMTECT < 9), indicating dementia

Exclusion Criteria:

  • medical conditions not allowing testing
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401582

Contacts
Contact: Jochen René Thyrian, PhD +49383486 ext 7592 rene.thyrian@dzne.de

Locations
Germany
Institute for Community Medicine Not yet recruiting
Greifswald, Mecklenburg- Western Pommerania, Germany, 17489
Contact: Jochen René Thyrian    +49383486 ext 7592    rene.thyrian@dzne.de   
Principal Investigator: Wolfgang Hoffmann         
Sub-Investigator: Jochen René Thyrian         
Sub-Investigator: Harald Freyberger         
Sub-Investigator: Steffen Fleßa         
Sub-Investigator: Hans-Jürgen Grabe         
Sub-Investigator: Stefan Teipel         
Sponsors and Collaborators
German Center for Neurodegenerative Diseases (DZNE)
University Medicine Greifswald
Investigators
Principal Investigator: Wolfgang Hoffmann, MD, MPH University Medicine Greifswald
  More Information

Publications:
Zank S, Schacke C, Leipold B. Berliner Inventar zur Angehörigenbelastung - Demenz (BIZA-D). Zeitschrift für Klinische Psychologie und Psychotherapie 2006; 35(4):296-305.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. Wolfgang Hoffmann, University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT01401582     History of Changes
Other Study ID Numbers: DZNE_DelpHi-MV_001
Study First Received: July 18, 2011
Last Updated: August 10, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by German Center for Neurodegenerative Diseases (DZNE):
health care
dementia care
caregiver support
epidemiological study

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014