Clinical trial NCT02472015: Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms
Official title: Dementia in Long Term Care Facilities: Telemedicine for the Management of Neuropsychiatric Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: neuropsychiatric symptoms
dementia
telemedicine
long-term care facilities
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 143
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Acceptability of the TM among the LTCF staff
timeFrame: 6 months
Secondary outcomes:
measure: Rate of non-programmed hospitalizations and/or consultation due to disruptive NPS
timeFrame: 6 months
measure: The psychotropic drugs used
timeFrame: 6 months
measure: describe the health costs
timeFrame: 6 months
measure: describe the estimation of the cluster effect ("design effect")
timeFrame: 6 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: UHLimoges
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Maria Soto, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.