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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02472015
Other study ID # 13 7031 08
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date November 2017

Study information

Verified date May 2023
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
telemedicine
psycho-behavioural care by telemedicine

Locations

Country Name City State
France UHLimoges Limoges
France UHToulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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):10 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 6 months
Secondary 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 6 months
Secondary The psychotropic drugs used Description of psychotropic drugs used in both groups 6 months
Secondary describe the health costs Description of the health costs in both groups 6 months
Secondary describe the estimation of the cluster effect ("design effect") Estimation of the cluster effect ("design effect") in both groups 6 months
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