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ClinicalTrials.gov Identifier: NCT02118701
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : May 19, 2017
Information provided by (Responsible Party):
Radboud University Medical Center

Brief Summary:

Shared Decision Making (SDM) is defined as a process where healthcare professionals and patients make decisions together, using the best available evidence. SDM, as a communication and decision method, can be used also with persons suffering from dementia. Yet, SDM with persons with dementia or even with their family caregivers is not widespread.

The present research project aims to develop and evaluate an SDM framework in care planning to be implemented in long-term care facilities, in order to obtain a constantly developing care plan that focuses not only on the medical, physical, psychosocial and spiritual needs of the resident, but that considers and documents his preferences and the actions taken by caregivers to meet them.

The current project is a controlled exploratory study. Case studies that involve a triad in each case, composed by the resident with moderate or severe dementia, his family caregiver and the professional usually taking care for the resident, will be used (n=16 professionals; n=40 residents; n=40 family caregivers). Professional caregivers of two nursing homes, one located in Italy and one in the Netherlands, will receive a specific training in SDM principles and will guide the SDM interview within the triad. Primary outcome will be the proportion of residents whose preferences and needs, together with the related actions to meet them, are known, documented and satisfied in their 'life-and-care plans'. Secondary outcomes are the residents' and family caregivers' quality of life; the family caregivers' sense of competence and the healthcare professionals' job satisfaction. Semi-structured interviews and focus group interviews will be performed to assess satisfaction with the intervention and barriers and facilitators to its implementation. Assessments are performed at baseline and six months after the intervention.

We hypothesize that the use of the SDM process in care planning will increase the number of met needs and will improve the residents' and family caregivers quality of life, the family caregivers' sense of competence and the healthcare professionals' job satisfaction.

The key element of this study is that it will contribute to our knowledge about the efficacy and feasibility of an SDM framework in care planning in long-term care facilities with persons with moderate to severe dementia.

Condition or disease Intervention/treatment Phase
Dementia Other: Shared Decision-Making educational training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : January 2014
Actual Primary Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SDM care planning Other: Shared Decision-Making educational training

Primary Outcome Measures :
  1. The proportion of residents whose preferences and needs, together with the related actions to meet them, are known, documented and satisfied in their 'life-and-care plans'. [ Time Frame: 6 months after the SDM interview ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • diagnosis of dementia based on the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV
  • from moderate to severe cognitive decline (Global Deterioration Scale from 4 to 6)
  • supported by a family caregiver who can be involved

Exclusion Criteria:

  • unable to pronounce simple sentences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT02118701    
Other Study ID Numbers: 258883
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2015
Keywords provided by Radboud University Medical Center:
Shared decision making
Long-term care
Nursing home
Care plan
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders