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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT02472015
Collaborator
(none)
143
2
2
29
71.5
2.5

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: telemedicine
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
143 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 :
Jun 1, 2015
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Acceptability of the TM among the LTCF staff [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 [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 [6 months]

    Description of psychotropic drugs used in both groups

  3. describe the health costs [6 months]

    Description of the health costs in both groups

  4. describe the estimation of the cluster effect ("design effect") [6 months]

    Estimation of the cluster effect ("design effect") in both groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UHLimoges Limoges France 87042
2 UHToulouse Toulouse France 31300

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Maria Soto, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02472015
Other Study ID Numbers:
  • 13 7031 08
First Posted:
Jun 15, 2015
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022