Dementiaintersec-CMNCT03359408
Supporting Elderly People With Cognitive Impairment During and After Hospital Stays- Intersectoral Care Management
A study testing Dementia Care Management (DCM) in people with Dementia and Cognitive Impairment, run by German Center for Neurodegenerative Diseases (DZNE) at 4 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Dementia, Cognitive Impairment, Neurodegenerative Diseases
- What is being tested?
- Dementia Care Management (DCM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Nov 2018to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70+ years
- minimum hospital stay of 5 days
- living at home
- positive cognitive screening (MMSE)
- written informed consent
Who cannot join
- stroke
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Evangelisches Klinikum Bethel gGmbH
Bielefeld, North Rhine-Westphalia, 33617
Ruhr University Bochum (RUB)
Bochum, North-Rhine-Westfalia, 44780
University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475
German Center for Neurodegenerative Diseases (DZNE)
Greifswald, 17489
About this study
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]
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.
Read the detailed description
The German health care system is sectorized with health service providers offering a) outpatient treatment and care, b) inpatient treatment and care or c) rehabilitation. While treatment and care within these sectors can be considered to be of high quality, there is a lack of widely available approaches to deliver treatment and care across sectors. Treatment paths for people with chronic diseases or the requirements of elderly people suffering from multimorbidity need frequent transitions between sectors. However, in Germany boundaries of sectors are considered rigid and transitions between sectors are a threat to treatment continuity, which results in inefficient treatment. As this problem has been identified and described by the Advisory Council on the Assessment of Developments in the Health Care System (Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen) already in 20121, different approaches have been proposed. This study addresses the lack of integrated cross-sectoral approaches to overcome the challenges caused by the sectorized German health care system.There is sound scientific evidence internationally and nationally that collaborative concepts of care can improve treatment and care of people with dementia in primary care (Thyrian et al. 2017). Those concepts are person-centered in the sense of a) taking into account the individual needs, circumstances and priorities, and b) aiming at outcomes relevant to the individuals life, like everyday functionality, (health related) quality of life and social inclusion.
The trial is a complex, longitudinal, multisite randomized controlled trial (intervention vs. care as usual). Recruitment of the study population will be conducted in two participating hospitals. After meeting the eligibility criteria, participants will be asked for written informed consent. With all participants a basic baseline assessment will be conducted (T0) in the hospital. After that they will be randomized in either the intervention group or control group. The intervention group will then receive the intervention, the control group care as usual. Further data assessments will be conducted at all participants´ home 3 months after discharge (T1) and at the participants´ home 12 months after discharge (T2). A process evaluation will also be applied in this study. Data assessment will be conducted by specifically trained study staff. Places of assessment are chosen for the highest possible convenience for the participants. Data assessments will include a) primary data from the participants being assessed, computer-assisted, face-to face and paper-pencil, b) secondary data from patient records in the hospital and from treating physicians.
The main research question of this protocol addresses the effectiveness of Dementia Care Management (DCM) in the intersectoral setting for people with cognitive impairment (PCI) in treatment and care across the in-hospital and primary care sector. The investigators will test the hypothesis if PCI receiving DCM initiated in hospitals and continued after discharge into ambulatory care do have better health and social outcomes after one year than PCI not receiving DCM. The patient-oriented minor hypotheses of this protocol are: ICM improves (a) health related quality of life sustainable, (b) social functioning and integration and (c) adequate treatment and care for dementia and co-morbidities in the ambulatory setting. It reduces (d) the risk for drug related problems in cognitive impairment and comorbidities and (e) the risk for re-admission to the hospital. The intervention prevents (f) incident delirium - given better awareness in respect to precipitating factors. The healthcare provider-oriented minor hypotheses are: ICM (a) reduces re-admission rates and thus saves costs in the inpatient setting. It increases (b) the chances to delay institutionalization significantly and thus saves costs from perspective of statutory health insurance. It (c) improves communication and exchange between treatment and care provider from different health care sectors sustainable. Furthermore, this protocol evaluates the process of implementing ICM along the main research question: How is ICM evaluated and rated among the different groups affected by it? Specific research questions are: What are the perceived benefits for (a) the providers (in the inpatient setting, (b) providers in the ambulatory setting, (c) the PCI and their caregiver? Is ICM evaluated as (d) improving communication and exchange between treatment and care provider from different health care sectors sustainable? And last not least, (e) what are the enablers and barriers to implement ICM in routine care?
- Conditions
- Dementia, Cognitive Impairment, Neurodegenerative Diseases
- Being tested
- Dementia Care Management (DCM)
- Keywords
- Health care, Dementia care, Collaborative care, Discharge management, Hospital, Primary care
- Medical subject headings
- Dementia, Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia Care Management (DCM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Care as usual | No intervention | Care as usual, no intervention, just observation of natural change/ trajectories over time |
| Dementia Care Management (DCM) | Experimental | Subjects in this arm will be provided with "Dementia Care Management" adapted to the intersectoral setting. Receives: Behavioral: Dementia Care Management (DCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrumental and Physical Functionality
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.
Measured: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
Re-Admission to Hospital
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.
Measured: Assessed 3 months and 12 months after the time of hospital discharge (T1, T2).
Institutionalisation
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.
Measured: Assessed 12 months after the time of hospital discharge (T2).
Secondary outcomes (8)
Change in Quality of Life
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.
Measured: Assessed at T1 (time of hospital discharge, on average 12 days after admission), T2 (3 months after T1) and T3 (12 months after T1)
Frailty
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.
Measured: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
Cognitive Status
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.
Measured: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
Resource Utilisation
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.
Measured: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
Use of Medical and Non-Medical Services
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.
Measured: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
Behavioral and Psychological Symptoms of Dementia
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).
Measured: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
Depression
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.
Measured: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
Caregiver Burden
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.
Measured: Assessed at T1 (time of hospital discharge, on average 12 days after admission), T2 (3 months after T1) and T3 (12 months after T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Nov 2018
- Primary completion31 Oct 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Sponsor type
- University, hospital or other
- Collaborators
- University Medicine Greifswald, Evangelisches Klinikum Bethel gGmbH, Jena University Hospital, German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, René Thyrian, German Center for Neurodegenerative Diseases (DZNE)
- Investigators
- Jochen René Thyrian, PhD, Principal investigator, German Center for Neurodegenerative Diseases (DZNE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359408
- Sponsor's protocol ID
- GR007
- Acronym
- intersec-CM
- Status last verified
- Sep 2022
- First submitted
- 16 Nov 2017
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the current status of the study, this has not been discussed with the funder and the research partners (11/13/17).
Publications
Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
PubMed 12021425Erzigkeit H, Lehfeld H, Pena-Casanova J, Bieber F, Yekrangi-Hartmann C, Rupp M, Rappard F, Arnold K, Hindmarch I. The Bayer-Activities of Daily Living Scale (B-ADL): results from a validation study in three European countries. Dement Geriatr Cogn Disord. 2001 Sep-Oct;12(5):348-58. doi: 10.1159/000051280.
PubMed 11455136Cockrell JR, Folstein MF. Mini-Mental State Examination (MMSE). Psychopharmacol Bull. 1988;24(4):689-92. No abstract available.
PubMed 3249771Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
PubMed 8232972Zaudig M, Mittelhammer J, Hiller W, Pauls A, Thora C, Morinigo A, Mombour W. SIDAM--A structured interview for the diagnosis of dementia of the Alzheimer type, multi-infarct dementia and dementias of other aetiology according to ICD-10 and DSM-III-R. Psychol Med. 1991 Feb;21(1):225-36. doi: 10.1017/s0033291700014811.
PubMed 2047500Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
PubMed 9153155Sheikh JI, Yesavage JA, Brooks JO 3rd, Friedman L, Gratzinger P, Hill RD, Zadeik A, Crook T. Proposed factor structure of the Geriatric Depression Scale. Int Psychogeriatr. 1991 Spring;3(1):23-8. doi: 10.1017/s1041610291000480.
PubMed 1863703Seidl H, Bowles D, Bock JO, Brettschneider C, Greiner W, Konig HH, Holle R. [FIMA--questionnaire for health-related resource use in an elderly population: development and pilot study]. Gesundheitswesen. 2015 Jan;77(1):46-52. doi: 10.1055/s-0034-1372618. Epub 2014 May 7. German.
PubMed 24806594Wimo A, Jonsson L, Zbrozek A. The Resource Utilization in Dementia (RUD) instrument is valid for assessing informal care time in community-living patients with dementia. J Nutr Health Aging. 2010 Oct;14(8):685-90. doi: 10.1007/s12603-010-0316-2.
PubMed 20922346Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
PubMed 7203086Thyrian JR, Hertel J, Wucherer D, Eichler T, Michalowsky B, Dreier-Wolfgramm A, Zwingmann I, Kilimann I, Teipel S, Hoffmann W. Effectiveness and Safety of Dementia Care Management in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Oct 1;74(10):996-1004. doi: 10.1001/jamapsychiatry.2017.2124.
PubMed 28746708Thyrian JR. [People with dementia in primary care : Prevalence, incidence, risk factors and interventions]. Z Gerontol Geriatr. 2017 May;50(Suppl 2):32-38. doi: 10.1007/s00391-017-1223-5. Epub 2017 Apr 6. German.
PubMed 28386806Dreier A, Thyrian JR, Eichler T, Hoffmann W. Qualifications for nurses for the care of patients with dementia and support to their caregivers: A pilot evaluation of the dementia care management curriculum. Nurse Educ Today. 2016 Jan;36:310-7. doi: 10.1016/j.nedt.2015.07.024. Epub 2015 Jul 31.
PubMed 26277428Eichler T, Thyrian JR, Fredrich D, Kohler L, Wucherer D, Michalowsky B, Dreier A, Hoffmann W. The benefits of implementing a computerized intervention-management-system (IMS) on delivering integrated dementia care in the primary care setting. Int Psychogeriatr. 2014 Aug;26(8):1377-85. doi: 10.1017/S1041610214000830. Epub 2014 May 9.
PubMed 24811145Eichler T, Thyrian JR, Dreier A, Wucherer D, Kohler L, Fiss T, Bowing G, Michalowsky B, Hoffmann W. Dementia care management: going new ways in ambulant dementia care within a GP-based randomized controlled intervention trial. Int Psychogeriatr. 2014 Feb;26(2):247-56. doi: 10.1017/S1041610213001786. Epub 2013 Oct 23.
PubMed 24152974
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT03359408
- Acronym / sponsor ID
- intersec-CM / GR007
- Conditions
- Dementia, Cognitive Impairment, Neurodegenerative Diseases
- Keywords
- Health care, Dementia care, Collaborative care, Discharge management, Hospital, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)University, hospital or other
- Collaborators
- University Medicine Greifswald, Evangelisches Klinikum Bethel gGmbH, Jena University Hospital, German Federal Ministry of Education and Research
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The German health care system is sectorized with health service providers offering a) outpatient treatment and care, b) inpatient treatment and care or c) rehabilitation. While treatment and care within these sectors can be considered to be of high quality, there is a lack of widely available approaches to deliver treatment and care across sectors. Treatment paths for people with chronic diseases or the requirements of elderly people suffering from multimorbidity need frequent transitions between sectors. However, in Germany boundaries of sectors are considered rigid and transitions between sectors are a threat to treatment continuity, which results in inefficient treatment. As this problem has been identified and described by the Advisory Council on the Assessment of Developments in the Health Care System (Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen) already in 20121, different approaches have been proposed. This study addresses the lack of integrated cross-sectoral approaches to overcome the challenges caused by the sectorized German health care system.There is sound scientific evidence internationally and nationally that collaborative concepts of care can improve treatment and care of people with dementia in primary care (Thyrian et al. 2017). Those concepts are person-centered in the sense of a) taking into account the individual needs, circumstances and priorities, and b) aiming at outcomes relevant to the individuals life, like everyday functionality, (health related) quality of life and social inclusion.
The trial is a complex, longitudinal, multisite randomized controlled trial (intervention vs. care as usual). Recruitment of the study population will be conducted in two participating hospitals. After meeting the eligibility criteria, participants will be asked for written informed consent. With all participants a basic baseline assessment will be conducted (T0) in the hospital. After that they will be randomized in either the intervention group or control group. The intervention group will then receive the intervention, the control group care as usual. Further data assessments will be conducted at all participants´ home 3 months after discharge (T1) and at the participants´ home 12 months after discharge (T2). A process evaluation will also be applied in this study. Data assessment will be conducted by specifically trained study staff. Places of assessment are chosen for the highest possible convenience for the participants. Data assessments will include a) primary data from the participants being assessed, computer-assisted, face-to face and paper-pencil, b) secondary data from patient records in the hospital and from treating physicians.
The main research question of this protocol addresses the effectiveness of Dementia Care Management (DCM) in the intersectoral setting for people with cognitive impairment (PCI) in treatment and care across the in-hospital and primary care sector. The investigators will test the hypothesis if PCI receiving DCM initiated in hospitals and continued after discharge into ambulatory care do have better health and social outcomes after one year than PCI not receiving DCM. The patient-oriented minor hypotheses of this protocol are: ICM improves (a) health related quality of life sustainable, (b) social functioning and integration and (c) adequate treatment and care for dementia and co-morbidities in the ambulatory setting. It reduces (d) the risk for drug related problems in cognitive impairment and comorbidities and (e) the risk for re-admission to the hospital. The intervention prevents (f) incident delirium - given better awareness in respect to precipitating factors. The healthcare provider-oriented minor hypotheses are: ICM (a) reduces re-admission rates and thus saves costs in the inpatient setting. It increases (b) the chances to delay institutionalization significantly and thus saves costs from perspective of statutory health insurance. It (c) improves communication and exchange between treatment and care provider from different health care sectors sustainable. Furthermore, this protocol evaluates the process of implementing ICM along the main research question: How is ICM evaluated and rated among the different groups affected by it? Specific research questions are: What are the perceived benefits for (a) the providers (in the inpatient setting, (b) providers in the ambulatory setting, (c) the PCI and their caregiver? Is ICM evaluated as (d) improving communication and exchange between treatment and care provider from different health care sectors sustainable? And last not least, (e) what are the enablers and barriers to implement ICM in routine care?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care as usual | No intervention | –Care as usual, no intervention, just observation of natural change/ trajectories over time |
| Dementia Care Management (DCM) | Experimental | Behavioral: Dementia Care Management (DCM)Subjects in this arm will be provided with "Dementia Care Management" adapted to the intersectoral setting. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 70+ years
- minimum hospital stay of 5 days
- living at home
- positive cognitive screening (MMSE)
- written informed consent
Key exclusion criteria (1 listed)
- stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Dementia Care Management (DCM) |
Primary outcome
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.
8 secondary outcomes
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)
Frailty
Time frame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
Cognitive Status
Time frame: Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)
Resource Utilisation
Time frame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
Use of Medical and Non-Medical Services
Time frame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
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)
Depression
Time frame: Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Background: PubMed 12021425Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.
- Background: PubMed 11455136Erzigkeit H, Lehfeld H, Pena-Casanova J, Bieber F, Yekrangi-Hartmann C, Rupp M, Rappard F, Arnold K, Hindmarch I. The Bayer-Activities of Daily Living Scale (B-ADL): results from a validation study in three European countries. Dement Geriatr Cogn Disord. 2001 Sep-Oct;12(5):348-58. doi: 10.1159/000051280.
- Background: PubMed 3249771Cockrell JR, Folstein MF. Mini-Mental State Examination (MMSE). Psychopharmacol Bull. 1988;24(4):689-92. No abstract available.
- Background: PubMed 8232972Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
- Background: PubMed 2047500Zaudig M, Mittelhammer J, Hiller W, Pauls A, Thora C, Morinigo A, Mombour W. SIDAM--A structured interview for the diagnosis of dementia of the Alzheimer type, multi-infarct dementia and dementias of other aetiology according to ICD-10 and DSM-III-R. Psychol Med. 1991 Feb;21(1):225-36. doi: 10.1017/s0033291700014811.
- Background: PubMed 9153155Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
- Background: PubMed 1863703Sheikh JI, Yesavage JA, Brooks JO 3rd, Friedman L, Gratzinger P, Hill RD, Zadeik A, Crook T. Proposed factor structure of the Geriatric Depression Scale. Int Psychogeriatr. 1991 Spring;3(1):23-8. doi: 10.1017/s1041610291000480.
- Background: PubMed 24806594Seidl H, Bowles D, Bock JO, Brettschneider C, Greiner W, Konig HH, Holle R. [FIMA--questionnaire for health-related resource use in an elderly population: development and pilot study]. Gesundheitswesen. 2015 Jan;77(1):46-52. doi: 10.1055/s-0034-1372618. Epub 2014 May 7. German.
- Background: PubMed 20922346Wimo A, Jonsson L, Zbrozek A. The Resource Utilization in Dementia (RUD) instrument is valid for assessing informal care time in community-living patients with dementia. J Nutr Health Aging. 2010 Oct;14(8):685-90. doi: 10.1007/s12603-010-0316-2.
- Background: PubMed 7203086Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
- Background: PubMed 28746708Thyrian JR, Hertel J, Wucherer D, Eichler T, Michalowsky B, Dreier-Wolfgramm A, Zwingmann I, Kilimann I, Teipel S, Hoffmann W. Effectiveness and Safety of Dementia Care Management in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Oct 1;74(10):996-1004. doi: 10.1001/jamapsychiatry.2017.2124.
- Background: PubMed 28386806Thyrian JR. [People with dementia in primary care : Prevalence, incidence, risk factors and interventions]. Z Gerontol Geriatr. 2017 May;50(Suppl 2):32-38. doi: 10.1007/s00391-017-1223-5. Epub 2017 Apr 6. German.
- Individual participant dataSharing planned: Undecided. At the current status of the study, this has not been discussed with the funder and the research partners (11/13/17).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen René Thyrian, PhD principal investigator
German Center for Neurodegenerative Diseases (DZNE)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Care Management (DCM) in people with Dementia and Cognitive Impairment, run by German Center for Neurodegenerative Diseases (DZNE) at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03359408, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.