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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
telemedicine
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring neuropsychiatric symptoms, dementia, telemedicine, long-term care facilities

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UHLimoges
  • UHToulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

normal care

telemedicine

Arm Description

patients who will have normal care

patients who will have telemedicine

Outcomes

Primary Outcome Measures

Acceptability of the TM among the LTCF staff
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

Rate of non-programmed hospitalizations and/or consultation due to disruptive NPS
Calculation of the rate of non-programmed hospitalizations and/or consultation due to disruptive NPS in both groups
The psychotropic drugs used
Description of psychotropic drugs used in both groups
describe the health costs
Description of the health costs in both groups
describe the estimation of the cluster effect ("design effect")
Estimation of the cluster effect ("design effect") in both groups

Full Information

First Posted
June 1, 2015
Last Updated
May 31, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02472015
Brief Title
Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms
Acronym
DETECT
Official Title
Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
neuropsychiatric symptoms, dementia, telemedicine, long-term care facilities

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal care
Arm Type
No Intervention
Arm Description
patients who will have normal care
Arm Title
telemedicine
Arm Type
Experimental
Arm Description
patients who will have telemedicine
Intervention Type
Procedure
Intervention Name(s)
telemedicine
Intervention Description
psycho-behavioural care by telemedicine
Primary Outcome Measure Information:
Title
Acceptability of the TM among the LTCF staff
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of non-programmed hospitalizations and/or consultation due to disruptive NPS
Description
Calculation of the rate of non-programmed hospitalizations and/or consultation due to disruptive NPS in both groups
Time Frame
6 months
Title
The psychotropic drugs used
Description
Description of psychotropic drugs used in both groups
Time Frame
6 months
Title
describe the health costs
Description
Description of the health costs in both groups
Time Frame
6 months
Title
describe the estimation of the cluster effect ("design effect")
Description
Estimation of the cluster effect ("design effect") in both groups
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Soto, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHLimoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
UHToulouse
City
Toulouse
ZIP/Postal Code
31300
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
29895651
Citation
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.
Results Reference
background
PubMed Identifier
32771311
Citation
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.
Results Reference
result

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

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