- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02472015
Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms (DETECT)
Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms.
Study Overview
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.
The two university hospitals are composed of a group of institutions for elderly people located near Toulouse and Limoges.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Limoges, France, 87042
- UHLimoges
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Toulouse, France, 31300
- UHToulouse
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: normal care
patients who will have normal care
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Experimental: telemedicine
patients who will have telemedicine
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psycho-behavioural care by telemedicine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
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The psychotropic drugs used
Time Frame: 6 months
|
Description of psychotropic drugs used in both groups
|
6 months
|
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describe the health costs
Time Frame: 6 months
|
Description of the health costs in both groups
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6 months
|
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describe the estimation of the cluster effect ("design effect")
Time Frame: 6 months
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Estimation of the cluster effect ("design effect") in both groups
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6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria Soto, MD, University Hospital, Toulouse
Publications and helpful links
General Publications
- Piau A, Nourhashemi F, De Mauleon A, Tchalla A, Vautier C, Vellas B, Duboue M, Costa N, Rumeau P, Lepage B, Soto Martin M. Telemedicine for the management of neuropsychiatric symptoms in long-term care facilities: the DETECT study, methods of a cluster randomised controlled trial to assess feasibility. BMJ Open. 2018 Jun 12;8(6):e020982. doi: 10.1136/bmjopen-2017-020982.
- Piau A, Vautier C, De Mauleon A, Tchalla A, Rumeau P, Nourhashemi F, Soto-Martin M. Health workers perception on telemedicine in management of neuropsychiatric symptoms in long-term care facilities: Two years follow-up. Geriatr Nurs. 2020 Nov-Dec;41(6):1000-1005. doi: 10.1016/j.gerinurse.2020.07.009. Epub 2020 Aug 6.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13 7031 08
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