Supporting Elderly People With Cognitive Impairment During and After Hospital Stays- Intersectoral Care Management (intersec-CM)
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|ClinicalTrials.gov Identifier: NCT03359408|
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : September 7, 2022
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Sectorisation of the German health care system causes inefficient treatment, especially in elderly with cognitive impairments. At time of transition from hospitals into primary care it lacks, among others, coordination of post-operative care or timely communication between healthcare providers. This results in deterioration of disease and comorbidities, higher rates of re-admission and institutionalizations. Models of collaborative care have shown their efficacy in primary care. Main goal is to test the effectiveness of Dementia Care Management (DCM) for people with cognitive impairment to improve treatment and care across the in-hospital and primary care sector.
The study design is a complex, longitudinal, multisite randomized controlled trial. It was designed to treat a hospital-based epidemiological cohort of people above the age of 70 with an adaption of DCM, a treatment proven to be effective in primary care, to the discharge setting. As part of this, specifically trained study staff will develop, implement and monitor a treatment and care plan, based on comprehensive assessments during the hospital stay, recommendations at discharge and unmet needs at home. For the 3 months after discharge study staff will coordinate treatment and care in close cooperation with the discharging hospital, treating physician and other care providers.
Expected results from the study should facilitate the implementation of intersectoral care management systematically on a large scale. Thus, the benefits shown in the trial would be available to a larger population. Results will not be limited to PCI, but rather to any people transitioning between the in-hospital and the primary care sector. Thus, the benefits would be available to elderly people in general.
|Condition or disease||Intervention/treatment||Phase|
|Dementia Cognitive Impairment Neurodegenerative Diseases||Behavioral: Dementia Care Management (DCM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||401 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Supporting Elderly People With Cognitive Impairment During and After Hospital Stays- Intersectoral Care Management [Verbundprojekt Intersec-CM - sektorenübergreifendes Care Management Zur Unterstützung Kognitiv beeinträchtigter Menschen während Und Nach Einem Krankenhausaufenthalt]|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||October 31, 2021|
|Actual Study Completion Date :||January 31, 2022|
No Intervention: Care as usual
Care as usual, no intervention, just observation of natural change/ trajectories over time
Experimental: Dementia Care Management (DCM)
Subjects in this arm will be provided with "Dementia Care Management" adapted to the intersectoral setting.
Behavioral: Dementia Care Management (DCM)
A specialised discharge management, based on "Dementia Care Management" (DCM; Thyrian et al. 2017, Eichler, Thyrian, Fredrich et al. 2014, Eichler, Thyrian, Dreier et al. 2014, Dreier et al. 2016, ) will be applied to subjects with cognitive impairment. Specifically qualified will conduct comprehensive data assessments during the hospital stay, assess recommendations at discharge and assess unmet needs at home. Supported by a a computerized Intervention Management (IMS) and in close cooperation with the discharging hospital, treating physicians and other care providers, they will develop, implement and monitor a treatment and care plan. Interventional home visits will take place at the participants homes.
- Instrumental and Physical Functionality [ Time Frame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge) ]The Bayer Activities of Daily Living Scale (B-ADL; Erzigkeit et al., 2001) will be used. It consists 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.
- Re-Admission to Hospital [ Time Frame: Assessed 3 months and 12 months after the time of hospital discharge (T1, T2). ]Participant will be asked if he/she has been hospitalized within the last 12 months. This is one item in the "the Questionnaire for the Use of Medical and Non-Medical Services in Old Age"; FIMA; (Seidl et al., 2015) which is administered to assess utilisation of health services.
- Institutionalisation [ Time Frame: Assessed 12 months after the time of hospital discharge (T2). ]Participant will be asked if he/she changed his/her living situation during the last 12 months. The answer will be validated with the question what the participants current living situation is. Both questions are items in the "the Questionnaire for the Use of Medical and Non-Medical Services in Old Age"; FIMA; (Seidl et al., 2015) which is administered to assess utilisation of health services.
- Change in Quality of Life [ Time Frame: Assessed at T1 (time of hospital discharge, on average 12 days after admission), T2 (3 months after T1) and T3 (12 months after T1) ]Quality of life will be assessed using the EQ-5D, a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. As proxy rating the questionnaire QUALIDEM [Ettema et al., 2007] will be used to assess the quality of life of people with dementia aged ≥ 65 years.
- Frailty [ Time Frame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge) ]Frailty will be assessed using the Edmonton frailty scale (EFS; Rolfson et al. 2006) will be used. The EFS is reliable tool in geriatric medicine to assess the frailty of older patients on the domains Cognition, General health status, Functional independence, Social support, Medication use, Nutrition, Mood, Continence and Functional performance.
- Cognitive Status [ Time Frame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge) ]The Mini Mental State Examination (MMSE; Cockrell & Folstein, 1988) will be used. The MMSE is a 30-point questionnaire to measure cognitive impairment. The questions are grouped into seven categories, each representing a different cognitive domain or function: Orientation to time (5 points); Orientation to place (5 points); Registration of three words (3 points); Attention and Calculation (5 points); Recall of three words (3 points); Language (8 points) and Visual Construction (1 point). Scores of 25-30 out of 30 are considered normal; 21-24 as mild, 10-20 as moderate and <10 as severe impairment.
- Resource Utilisation [ Time Frame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge) ]The Resource Utilization in Dementia questionaire (RUD; Wimo et al., 2010) will be used to measure the frequency of utilisation of general physicians and physicians of other specialties, out-patient treatments, in-patient treatments, hospitalisations, institutionalisation and therapeutic appliances.
- Use of Medical and Non-Medical Services [ Time Frame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge) ]The Questionnaire for the Use of Medical and Non-Medical Services in Old Age [Fragebogen zur Inanspruchnahme medizinischer und nicht-medizinischer Versorgungsleistungen im Alter"; FIMA; Seidl et al., 2015) will be used. The FIMA examines socio-economic variables and other medical factors by determining health-related costs.
- Behavioral and Psychological Symptoms of Dementia [ Time Frame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge) ]Neuropsychiatric Inventory (NPI; Cummings 1997) will be used. 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 of each domain range: 0 to 144, the higher the more neuropsychiatric symptomatic).
- Depression [ Time Frame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge) ]The short form of the Geriatric Depression Scale (GDS; Yesavage & Sheikh,1986) will be used. It consists of 15 questions. One point is conferred for each positively answered question. Scores of 11 - 15 indicate the presence of depression, 5 - 10 a mild depression and 0 - 5 no depression.
- Caregiver Burden [ Time Frame: Assessed at T1 (time of hospital discharge, on average 12 days after admission), T2 (3 months after T1) and T3 (12 months after T1) ]The revised version of the Zarit-Burden Inventory (ZBI; Zarit et al., 1980) will be used.The revised version ZBI is a caregiver self-report measure to examine burden which is associated with functional/behavioural impairments and home care situation. It contains 22 items using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).Total scores range from 0 indicating low burden to 88 indicating high burden.
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|Ages Eligible for Study:||70 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 70+ years
- minimum hospital stay of 5 days
- living at home
- positive cognitive screening (MMSE)
- written informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359408
|University Medicine Greifswald|
|Greifswald, Mecklenburg-Vorpommern, Germany, 17475|
|Evangelisches Klinikum Bethel gGmbH|
|Bielefeld, Nordrhein-Westfalen, Germany, 33617|
|Ruhr University Bochum (RUB)|
|Bochum, North-Rhine-Westfalia, Germany, 44780|
|German Center for Neurodegenerative Diseases (DZNE)|
|Greifswald, Germany, 17489|
|Principal Investigator:||Jochen René Thyrian, PhD||German Center for Neurodegenerative Diseases (DZNE)|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||René Thyrian, Working Group leader, German Center for Neurodegenerative Diseases (DZNE)|
|Other Study ID Numbers:||
|First Posted:||December 2, 2017 Key Record Dates|
|Last Update Posted:||September 7, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||At the current status of the study, this has not been discussed with the funder and the research partners (11/13/17).|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
Nervous System Diseases