NCT03578861

Brief Summary

Objectives: Specific mobility programs can delay the functional decline in people with dementia (PwD) and help to preserve their abilities of daily living. Respite care is a common used short time inpatient service (max. 4 weeks of stay) to support dementia care arrangements. Within the DESKK project, a concept is developed which complements and optimizes dementia-specific respite care through a mobility program and a counseling program. As one part of the DESKK study, it is the aim to develop and implement a time effective and evidence based mobility program for PwD in respite care which can be individually adapted on PwD needs and preferences. It includes a short "homework-program" for caring relatives to facilitate ongoing mobility training of the PwD after returned back home. Methods: A pilot based, quasi-experimental evaluation study is conducted in a specialized respite care facility for PwD. The concept was developed on the basis of a comprehensive literature research, study visits at existing counseling programs as well as expert workshops with practitioners and scientists. To evaluate the implementation process, qualitative data are collected by single und group interviews. Quantitative data are collected using validated instruments to assess mobility and cognitive function of PwD. A mixed methods triangulation approach will be used to aggregate qualitative and quantitative data. Discussion: It is expected that the RC concept will be suitable and understandable for the staff, so that it can be implemented in the RC facility. As a result of the mobility program, the physical abilities of the PwDs should improve. Similar, the burden of the caregivers should be reduced by combined effects of the counselling program and the higher mobility level of the PwD. The whole DESKK concept, including a systematic counseling program for caring relatives, which is not part of this presentation, will be described in form of a practice friendly website to get disseminated into clinical routine after its successful evaluation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

February 11, 2019

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

June 18, 2018

Last Update Submit

February 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery (SPPB)

    The SPPB can be used for the analyses of ADL related capabilities of old people related to gait performance and strength as well related to static balance. This test can also be used for people with cognitive retardation. Furthermore the Instrument is validated and reliable.

    10 min

Secondary Outcomes (6)

  • Nurses' Observation Scale for Geriatric Patients (NOSGER)

    10 min

  • Nurses' Observation Scale for Geriatric Patients (MMST)

    25 min

  • Box and Blocks Test (BBT)

    5 min

  • Strength-Dexterity Test (SD)

    2 min

  • Nine-Hole Peg Test (NHPT)

    2 min

  • +1 more secondary outcomes

Study Arms (1)

Dementia related mobility and counseling

EXPERIMENTAL

The DESKK mobility program is based on the already existing day structure of the RC facility with two slots a day for physical activation activities (1 ½ hours forenoon and 1 ½ hours afternoon). The program structures these activities based on specific developed exercises, which are focused on the individual mobility level of every PwD and his/her mobility level. The DESKK counseling program is an effort to structure and systemize counseling processes focused on the respite care setting by different documents and assessments.

Other: Dementia related mobility and counseling

Interventions

The DESKK mobility program is based on the already existing day structure of the RC facility with two slots a day for physical activation activities (1 ½ hours forenoon and 1 ½ hours afternoon). The program structures these activities based on specific developed exercises, which are focused on the individual mobility level of every PwD and his/her mobility level. The DESKK counseling program is an effort to structure and systemize counseling processes focused on the respite care setting by different documents and assessments.

Dementia related mobility and counseling

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Caring relatives:
  • Willingness to take part at the counseling intervention (informed consent)
  • Sufficient language skills to understand the counseling sessions
  • CR has to be the primary care person for the PwD
  • People with dementia
  • Willingness to take part at the rehabilitation intervention (informed consent \[if necessary: signing by the primary care person\])
  • Capability to understand and follow (training) instructions with support of the involved training assessors (subjective pre-assessment by raters)
  • Capability to stand and walk short distances (min. 3 Meter) with support of the involved training assessors
  • Minimum amount of 13 days stay in the RC center (planned)

You may not qualify if:

  • Other severe cognitive impairments or other severe neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DZNE

Witten, 58453, Germany

Location

Related Publications (19)

  • Dassen, T. (2009). Bundesweite Erhebung zu Pflegeproblemen 2009. Studie aus Pflegeheimen und Krankenhäusern. Berlin: Charité.

    BACKGROUND
  • DAlzG. (2016). Informationblatt 1 - Die Häufigkeit von Demenzerkrankungen. Retrieved from https://www.deutsche-alzheimer.de/fileadmin/alz/pdf/factsheets/infoblatt1_haeufigkeit_demenzerkrankungen_dalzg.pdf

    BACKGROUND
  • WHO. (2012). Dementia - A public health priority. Retrieved from http://whqlibdoc.who.int/publications/2012/9789241564458_eng.pdf

    BACKGROUND
  • Radenbach K, Retzlik J, Meyer-Rotz SH, Wolff-Menzler C, Wolff J, Esselmann H, Godemann F, Riemenschneider M, Wiltfang J, Jessen F. [Guideline-adherent inpatient psychiatric psychotherapeutic treatment of behavioral and psychological symptoms of dementia : Normative definition of personnel requirements]. Nervenarzt. 2017 Sep;88(9):1010-1019. doi: 10.1007/s00115-016-0195-9. German.

    PMID: 27581115BACKGROUND
  • Reggentin H. [Caregiver's burden of caring for patients with dementia in group living compared to to domestic and inpatient care]. Z Gerontol Geriatr. 2005 Apr;38(2):101-7. doi: 10.1007/s00391-005-0295-9. German.

    PMID: 15868348BACKGROUND
  • Shea, T. (2012). Dementia - Understanding brain diseases and disorders. New York: Rosen Publishing.

    BACKGROUND
  • van Doorn C, Gruber-Baldini AL, Zimmerman S, Hebel JR, Port CL, Baumgarten M, Quinn CC, Taler G, May C, Magaziner J; Epidemiology of Dementia in Nursing Homes Research Group. Dementia as a risk factor for falls and fall injuries among nursing home residents. J Am Geriatr Soc. 2003 Sep;51(9):1213-8. doi: 10.1046/j.1532-5415.2003.51404.x.

    PMID: 12919232BACKGROUND
  • Forbes D, Forbes SC, Blake CM, Thiessen EJ, Forbes S. Exercise programs for people with dementia. Cochrane Database Syst Rev. 2015 Apr 15;2015(4):CD006489. doi: 10.1002/14651858.CD006489.pub4.

    PMID: 25874613BACKGROUND
  • Maayan N, Soares-Weiser K, Lee H. Respite care for people with dementia and their carers. Cochrane Database Syst Rev. 2014 Jan 16;2014(1):CD004396. doi: 10.1002/14651858.CD004396.pub3.

    PMID: 24435941BACKGROUND
  • Kurz A, Hallauer J, Jansen S, Diehl J. [Efficacy of caregiver support groups for dementia]. Nervenarzt. 2005 Mar;76(3):261-9. doi: 10.1007/s00115-004-1759-7. German.

    PMID: 15300316BACKGROUND
  • Heinrich S, Laporte Uribe F, Roes M, Hoffmann W, Thyrian JR, Wolf-Ostermann K, Holle B. Knowledge management in dementia care networks: a qualitative analysis of successful information and support strategies for people with dementia living at home and their family caregivers. Public Health. 2016 Feb;131:40-8. doi: 10.1016/j.puhe.2015.10.021. Epub 2015 Dec 21.

    PMID: 26718421BACKGROUND
  • ZQP. (2018). Ein Jahr nach letzter Pflegereform: Pflegende Angehörige sehen Informationsbedarf. Retrieved from https://www.presseportal.de/pm/80067/3876592?utm_source=digest&utm_medium=email&utm_campaign=push

    BACKGROUND
  • Gomez JF, Curcio CL, Alvarado B, Zunzunegui MV, Guralnik J. Validity and reliability of the Short Physical Performance Battery (SPPB): a pilot study on mobility in the Colombian Andes. Colomb Med (Cali). 2013 Sep 30;44(3):165-71. eCollection 2013 Jul.

    PMID: 24892614BACKGROUND
  • Mendes MF, Tilbery CP, Balsimelli S, Moreira MA, Cruz AM. [Box and block test of manual dexterity in normal subjects and in patients with multiple sclerosis]. Arq Neuropsiquiatr. 2001 Dec;59(4):889-94. doi: 10.1590/s0004-282x2001000600010. Portuguese.

    PMID: 11733833BACKGROUND
  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PMID: 1202204BACKGROUND
  • Spiegel R, Brunner C, Ermini-Funfschilling D, Monsch A, Notter M, Puxty J, Tremmel L. A new behavioral assessment scale for geriatric out- and in-patients: the NOSGER (Nurses' Observation Scale for Geriatric Patients). J Am Geriatr Soc. 1991 Apr;39(4):339-47. doi: 10.1111/j.1532-5415.1991.tb02897.x.

    PMID: 2010583BACKGROUND
  • Bruce-Keller AJ, Brouillette RM, Tudor-Locke C, Foil HC, Gahan WP, Nye DM, Guillory L, Keller JN. Relationship between cognitive domains, physical performance, and gait in elderly and demented subjects. J Alzheimers Dis. 2012;30(4):899-908. doi: 10.3233/JAD-2012-120025.

    PMID: 22466001BACKGROUND
  • Zank, S., Schacke, C., & Leipold, B. (2006). Berliner Inventar zur Angehörigenbelastung - Demenz (BIZA - D). Kurzbeschreibung und grundlegende Kennwerte. Retrieved from http://www.hf.uni-koeln.de/data/gerontologie/File/BIZA-D.pdf

    BACKGROUND
  • Heinrich S, Cavazzini C, Holle B. DESKK Study - Development and testing of a dementia-specific respite care concept with a mobility and counselling programme: study protocol. BMJ Open. 2019 Jun 14;9(6):e025932. doi: 10.1136/bmjopen-2018-025932.

Related Links

MeSH Terms

Conditions

Dementia

Interventions

Counseling

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Bernhard Holle, Dr

    DZNE Witten

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

July 6, 2018

Study Start

October 20, 2017

Primary Completion

September 20, 2018

Study Completion

November 1, 2018

Last Updated

February 11, 2019

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will share

Data will be available based on the informed consent of the participants. Data from the study can be requested from the first author via steffen.heinrich@dzne.de

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available in April 2019.
Access Criteria
E-Mail request via: steffen.heinrich@dzne.de
More information

Locations