Effectiveness of a Care Management System to Reduce Unmet Needs of Informal Caregivers of People With Dementia

NCT04037501 | Completed

• 2 other identifiers: GR00901VSF18030
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the effectiveness of a computer assisted care management system to identify and reduce unmet needs for and to improve quality of life of informal caregivers of people with dementia.

Conditions

Dementia; Caregiver Burnout; Carer Stress Syndrome; Relatives; Partner, Domestic

Keywords

Caregiver of people with dementia; Caregiver health; Care management system; Collaborative care; Informal care coordination; Dementia; Medical management; Unmet needs

Outcome Measures

Primary Outcomes (2)

• Change in number of Unmet Needs

  A standardized assessment implemented as computer-assisted intervention management system (CMS) addresses caregiver burden, medical needs, home care needs, psychosocial needs (depression, sleep quality, pain, hearing, seeing, teeth problems, dementia related problems caused by PwD, medical aids). Based on predefined algorithms the CMS will generate a list of recommended intervention to address each of the unmet needs.

  Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)

• Change in Quality of Life

  The questionnaire SF-12 (Short form of SF-36) will be used to assess quality of life. The SF-12 is a physical scale score that represents general health perception, physical functioning, physical role functioning, and pain. The mental health score represents emotional role functioning, mental well-being, negative affectivity, and social functioning. The mean score is set to 50. Scores higher than 50 indicate better physical or mental health than the mean while scores lower than 50 indicate worse physical mental health than the mean.

  Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]

Secondary Outcomes (3)

• Change in Caregiver Burden

  Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]

• Social Support

  Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)

• Use of medical and non-medical services

  : Baseline values assessed at time of visit to the physician (T0), Outcome value assessed 6 months later at concluding home visit (T6)]

Study Arms (2)

Intervention

EXPERIMENTAL

Other: Care Management

care as usual

NO INTERVENTION

Interventions

Care Management OTHER

A computerized Care Management System (CMS) will identify unmet needs of the informal caregiver of PwD and generates suggestions for interventions. Based on these, the treating physician develops an individualized treatment and care plan and assigns specific tasks to the care manager. Upon a home visit in the caregivers' home the care manager evaluates the need for additional tasks. Based on the complete list of tasks, the care manager initiates the implementation of respective actions. Via monthly telephone calls and optional home visits the care manager monitors the status of implementation and actively coordinates the support and care for the informal caregiver recommended intervention

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years
• main caregiver of a PwD (Hauptversorgungsperson)
• PwD lives at home
• written informed consent of caregiver

You may not qualify if:

• caregiver not living in the study region MV
• not able to provide written consent
• unable to fill out self-administered questionnaire an/or to be interviewed

Sponsors & Collaborators

• German Center for Neurodegenerative Diseases (DZNE): lead
• Gemeinsamer Bundesausschuss (GBA): collaborator
• University Medicine Greifswald: collaborator

Study Sites (1)

German Center for Neurodegenerative Diseases (DZNE)

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

Location

Related Publications (1)

• Klein OA, Boekholt M, Afrin D, Dornquast C, Dreier-Wolfgramm A, Keller A, Michalowsky B, Zwingmann I, Teipel S, Thyrian JR, Kilimann I, Hoffmann W. Effectiveness of a digitally supported care management programme to reduce unmet needs of family caregivers of people with dementia: study protocol for a cluster randomised controlled trial (GAIN). Trials. 2021 Jun 16;22(1):401. doi: 10.1186/s13063-021-05290-w.

  PMID: 34134744 DERIVED

MeSH Terms

Conditions

Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Wolfgang Hoffmann, MD

  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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site speaker

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: October 9, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)