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Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms (DETECT)

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ClinicalTrials.gov Identifier: NCT02472015
Recruitment Status : Active, not recruiting
First Posted : June 15, 2015
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Telemedicine may facilitate adequate treatment of Neuropsychiatric symptoms (NPS) by identifying underlying causes and tailoring a treatment plan (pharmacological or non-pharmacologic treatments including provision of staff education and support, training in problem solving, and targeted therapy directed at the underlying causes for specific behaviors).

Condition or disease Intervention/treatment Phase
Dementia Procedure: telemedicine Not Applicable

Detailed Description:

During a 6-months period, patients will be included in both arms, whenever they present a disruptive NPS that requires a specialist consultation based on the long-term care facility (LTCF) staff judgment. In the intervention group, a telemedicine (TM) consultation between the LTCF staff (medical and nurse staff) and the Memory Center from the University Hospital, will occur at inclusion (T0). Then, a second TM consultation will occur at 1 month (T1). In the control group management of NPS will be done as usual care. In both groups, patients' parameters such as non-programmed hospitalizations and/or consultations due to disruptive NPS, psychotropic drugs use, and health costs, will be evaluated at inclusion, 1 month and at 2 months. Acceptability of the TM among the LTCF staff will be assessed during the study in the intervention group.

In this feasability study, patients will be included by the University Hospital of Toulouse and the University Hospital of Limoges.

These two university hospitals are composed of a group of institutions for elderly people located near Toulouse and Limoges.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms.
Study Start Date : June 2015
Actual Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: normal care
patients who will have normal care
Experimental: telemedicine
patients who will have telemedicine
Procedure: telemedicine
psycho-behavioural care by telemedicine




Primary Outcome Measures :
  1. Acceptability of the TM among the LTCF staff [ Time Frame: 6 months ]
    Acceptability of the telemedicine (TM) among the LTCF staff which will be assessed in the intervention group by quantitative indicators (proportion of the solicitation of the TM solution among patients with disruptive NPS, the delay to obtain a TM consultation and the number of the staff participants at each TM consultation) and qualitative indicators (staff global satisfaction will be evaluated by focus groups and interviewing).


Secondary Outcome Measures :
  1. Rate of non-programmed hospitalizations and/or consultation due to disruptive NPS [ Time Frame: 6 months ]
    Calculation of the rate of non-programmed hospitalizations and/or consultation due to disruptive NPS in both groups

  2. The psychotropic drugs used [ Time Frame: 6 months ]
    Description of psychotropic drugs used in both groups

  3. describe the health costs [ Time Frame: 6 months ]
    Description of the health costs in both groups

  4. describe the estimation of the cluster effect ("design effect") [ Time Frame: 6 months ]
    Estimation of the cluster effect ("design effect") in both groups



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient aged 65 or more, with a dementia diagnosed by a specialist or the general practitioner;
  • patient presenting with a disruptive NPS as defined in French Haute Autorité de Santé (HAS) recommendations (2009), that requires a specialist consultation based on the LTCF staff judgment;
  • informed and written consent by the patient or the legal representative or the reliable person when appropriate;
  • general practitioner agreement.

Exclusion Criteria:

  • patient's life expectancy less than 6 months;
  • Non agreement of study participation of patients or legal representative or the reliable person when appropriate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472015


Locations
France
UHLimoges
Limoges, France, 87042
UHToulouse
Toulouse, France, 31300
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Maria Soto, MD University Hospital, Toulouse

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02472015     History of Changes
Other Study ID Numbers: 13 7031 08
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by University Hospital, Toulouse:
neuropsychiatric symptoms
dementia
telemedicine
long-term care facilities

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders