Supporting Elderly People With Cognitive Impairment During and After Hospital Stays- Intersectoral Care Management

NCT03359408 | Completed

• 1 other identifier: GR007
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Dementia; Cognitive Impairment; Neurodegenerative Diseases

Keywords

Health care; Dementia care; Collaborative care; Discharge management; Hospital; Primary care

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Assessed 12 months after the time of hospital discharge (T2).

Secondary Outcomes (8)

• Change in Quality of Life

  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

  Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)

• Cognitive Status

  Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)

• Resource Utilisation

  Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)

• Use of Medical and Non-Medical Services

  Assessed at T1 (3 months after discharge) and T2 (12 months after discharge)

Study Arms (2)

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.

Behavioral: Dementia Care Management (DCM)

Interventions

Dementia Care Management (DCM) BEHAVIORAL

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.

Dementia Care Management (DCM)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• + years
• minimum hospital stay of 5 days
• living at home
• positive cognitive screening (MMSE)
• written informed consent

You may not qualify if:

• stroke

Sponsors & Collaborators

• German Center for Neurodegenerative Diseases (DZNE): lead
• University Medicine Greifswald: collaborator
• Evangelisches Klinikum Bethel gGmbH: collaborator
• Jena University Hospital: collaborator
• German Federal Ministry of Education and Research: collaborator

Study Sites (4)

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Evangelisches Klinikum Bethel gGmbH

Bielefeld, North Rhine-Westphalia, 33617, Germany

Location

Ruhr University Bochum (RUB)

Bochum, North-Rhine-Westfalia, 44780, Germany

Location

German Center for Neurodegenerative Diseases (DZNE)

Greifswald, 17489, Germany

Location

Related Publications (23)

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• Boekholt M, Nikelski A, Schumacher-Schoenert F, Kracht F, Vollmar HC, Hoffmann W, Kreisel SH, Thyrian JR. Supporting older people with cognitive impairment during and after hospital stays with intersectoral care management (intersec-CM)-results of a randomised clinical trial. Age Ageing. 2025 Feb 2;54(2):afaf011. doi: 10.1093/ageing/afaf011.

  PMID: 39912589 DERIVED

• Kracht F, Boekholt M, Schumacher-Schonert F, Nikelski A, Chikhradze N, Lucker P, Vollmar HC, Hoffmann W, Kreisel SH, Thyrian JR. Describing people with cognitive impairment and their complex treatment needs during routine care in the hospital - cross-sectional results of the intersec-CM study. BMC Geriatr. 2021 Jul 12;21(1):425. doi: 10.1186/s12877-021-02298-4.

  PMID: 34253180 DERIVED

• Dehl T, Sauerbrey U, Dreier-Wolfgramm A, Nikelski A, Chikhradze N, Keller A, Laufer J, Schumacher-Schoenert F, Kreisel S, Thyrian JR, Hoffmann W, Vollmar HC. Intersectoral care management for older people with cognitive impairment during and after hospital stays [intersec-CM]: study protocol for a process evaluation within a randomised controlled trial. Trials. 2021 Jan 21;22(1):72. doi: 10.1186/s13063-021-05021-1.

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• Nikelski A, Keller A, Schumacher-Schonert F, Dehl T, Laufer J, Sauerbrey U, Wucherer D, Dreier-Wolfgramm A, Michalowsky B, Zwingmann I, Vollmar HC, Hoffmann W, Kreisel SH, Thyrian JR. Supporting elderly people with cognitive impairment during and after hospital stays with intersectoral care management: study protocol for a randomized controlled trial. Trials. 2019 Aug 30;20(1):543. doi: 10.1186/s13063-019-3636-5.

  PMID: 31470912 DERIVED

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Jochen René Thyrian, PhD

  German Center for Neurodegenerative Diseases (DZNE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Working Group leader

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: December 2, 2017
• Study Start: November 1, 2018
• Primary Completion: October 31, 2021
• Study Completion: January 31, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

DE (4)