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Trial record 1 of 2701 for:    Dementia
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Intervention Study to Improve Life and Care for People With Dementia and Their Caregivers in Primary Care (DelpHi)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Medicine Greifswald
Information provided by (Responsible Party):
René Thyrian, German Center for Neurodegenerative Diseases (DZNE)
ClinicalTrials.gov Identifier:
NCT01401582
First received: July 18, 2011
Last updated: April 3, 2017
Last verified: April 2017
  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 (MV), 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: Implementation of Dementia Care Manager

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator, Outcomes Assessor
Primary Purpose: Supportive Care
Official Title: Dementia: Life- and Personcentered Help in Germany

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Quality of Life [ Time Frame: one year after baseline assessment ]
    The Quality of Life in Alzheimer's Disease (Qol-AD; Logsdon et al. 2002) was used. This measure designed specifically to obtain a rating of the patient's quality of life from both the patient and the caregiver. Each item is rated on a four point scale, with 1 being poor and 4 being excellent. Total scores, obtained by the sum of all 13 items, range from 13 to 52.

  • Change in Caregiver Burden [ Time Frame: one year after baseline assessment ]
    Caregiver burden was assessed using the "Berliner Inventar zur Angehörigenbelastung - Demenz" (BIZA-D) (Zank et al., 2006). The BIZAD was developed to assess objective as well as subjective burden due to caring for a person wit dementia (PWD). It consists of 88 items covering 20 dimensions of caregiver burden. Objective burden is divided into six dimensions: 1) basic care tasks like support eating, hygiene etc (7 items), 2) extended care tasks like supporting grocery shopping, legal affairs etc. (3 items), 3) Motivation and Guidance (4 items), 4) emotional support (4 items), 5) supporting maintenance of social contacts (3 items) and 6) supervision (4 items). Each item has to be rated regarding the frequency of the support needed on a 5-Point scale (example: supervision; Does the patient need this kind of support: 1=always, 2= mostly, 3=partly, 4=hardly, 5= not at all). Then each item asks: Who is providing this support: all by someone else, mostly by someone else, evenly distributed

  • Change in Behavioral and Psychological Symptoms of Dementia [ Time Frame: one year after baseline assessment ]
    Neuropsychiatric Inventory (NPI; Cummings 1997); The NPI represents an interview by proxy on twelve dimensions of neuropsychiatric behaviors, i.e. delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The presence (0= no, 1= yes) is asked. If present, the severity (rated 1 through 3; mild to severe) and frequency (1 to 4, rarely to very often) of each neuropsychiatric symptom are rated on. Thus the score for each dimension ranges from 0 = not present, 1= mildly and rarely to 12 = severe and often. A total NPI score is calculated as the sum of the frequency by severity scores ofeach domain range: 0 to 144, the higher the more neuropsychiatric symptomatic).

  • Change in Medical Treatment With Antidementia Drugs [ Time Frame: one year after baseline assessment ]
    medication was systematically reviewed; A computer-based home medication review (HMR) encompasses all medications used by the study participants and includes questions about compliance, adverse effects and drug administration. The collection of primary data on medication in the context of the HMR includes both prescription drugs and over-the-counter drugs. The assignment was then integrated using a master file of the Pharmaceutical Index. The following antidementia drugs were considered: donepezil (N06AD02), rivastigmine (N06AD03), galantamine (N06AD04) and memantine (N06AX01).

  • Reduction of Potential Inapropriate Medication (PIM) [ Time Frame: one year after baseline assessment ]
    Having to deal with multimorbidity and polypharmacy in a sample of chronically ill elderly, we also analyze potentially inappropriate medication (PIM), defined as "a drug for which the risk of an adverse event outweighs the clinical benefit, particularly when there is evidence in favor of a safer or more effective alternative therapy for the same condition". The PIM were identified using the Priscus list, which contains 83 drugs from 18 different drug classes.


Secondary Outcome Measures:
  • Person With Dementia: Change in Activities of Daily Living [ Time Frame: one year after baseline assessment ]
    The functional status was assessed using the Bayer Activities of Daily Living Scale (B-ADL). It coonsits of 25 Items indicating everyday problems/ challenges. Their occurence is rated on a scale of 1 "never", to 10 "always". All ratings are added and divided by the number of items. This yields a mean score of 1 to 10, where 1 indicates the lowest possible impairment and 10 indicates the highest possible impairment.

  • Person With Dementia: Change in Cognitive Status - Omitted in 2014 Due to Burden on the Proband [ Time Frame: participants will be followed yearly until institutionalisation or death after an expected average of 5 years ]
    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 ]
    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 ]

    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 ]

    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 ]
    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


Enrollment: 634
Study Start Date: January 2012
Estimated Study Completion Date: March 2018
Primary Completion Date: March 2016 (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: Implementation of 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   70 Years to 120 Years   (Senior)
Sexes Eligible for Study:   All
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

Locations
Germany
Institute for Community Medicine
Greifswald, Mecklenburg- Western Pommerania, Germany, 17489
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:
Bullinger M, Kirchberger I. SF-36 Fragenbogen zum Gesundheitszustand. Göttingen 1998: Hogrefe-Verlag GmBH & Co.KG; 1998
Fydrich T, Sommer G, Brähler E. F-SozU. Fragebogen zur sozialen Unterstützung. Göttingen: Hogrefe; 2007.
Zank S, Schacke C, Leipold B. Berliner Inventar zur Angehörigenbelastung - Demenz (BIZA-D). Zeitschrift für Klinische Psychologie und Psychotherapie 2006; 35(4):296-305.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: René Thyrian, Research Group Leader, German Center for Neurodegenerative Diseases (DZNE)
ClinicalTrials.gov Identifier: NCT01401582     History of Changes
Other Study ID Numbers: DZNE_DelpHi-MV_001
Study First Received: July 18, 2011
Results First Received: October 17, 2016
Last Updated: April 3, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by René Thyrian, 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
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 28, 2017