Condition category
Mental and Behavioural Disorders
Date applied
24/02/2006
Date assigned
24/02/2006
Last edited
24/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin George Cole

ORCID ID

Contact details

St Mary's Hospital
Clinical Epidemiology & Community Study
3830 Lacombe Avenue
Room 2508
Montreal
H3T 1M5
Canada
martin.cole@ssss.gouv.qc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-15476

Study information

Scientific title

Effectiveness of a geriatric depression service in reducing the severity and symptoms of drepression and improving physical and mental health: a randomised controlled trial

Acronym

Study hypothesis

Primary objective:
To determine if systematic detection, treatment and follow-up by a geriatric depression service for medical inpatients aged 65 years or over in acute care hospital is effective in reducing the severity of symptoms of depression and in improving physical and mental health status at 12 and 24 weeks after enrolment.

Secondary objectives:
1. To determine the effects of the intervention upon impairment of basic and instrumental activities of daily living, cognitive status, medication side effects profile, mortality, and health service utilisation (length of stay, readmission, emergency visits, psychiatrist consultation, and visits to other physicians)
2. To describe the process of care

Ethics approval

Research Ethics Committee of St Mary's Hospital Center, Montreal Québec (Canada) approved on the 30th July 1998

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Depression

Intervention

1. Psychiatric consultation and treatment by a geriatric psychiatrist
2. Follow-up by a research nurse
3. Follow-up treatment by a family physician

Trial details received: 12 September 2005

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Changes in depressive symptoms: Hamilton Depression Rating Scale (HAMD) and 36-item Short Form health survey (SF-36)

Secondary outcome measures

1. Basic Activities of Daily Living (BADL)
2. Instrumental Activities of Daily Living (IADL)
3. Mini-Mental State Examination (MMSE)
4. Health services utilisation
5. Mortality
6. Medication side effects

Overall trial start date

01/04/1999

Overall trial end date

31/03/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Admission to medical units
2. Age 65 years and older, either sex
3. Short Portable Mental Status Questionnaire (SPMSQ) less than or equal to 4

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

156

Participant exclusion criteria

1. Admissions to intensive care unit or to cardiac monitoring unit: these patients are too acutely ill to participate but will be eligible if transferred to a medical ward within 72 hours of admission
2. Admissions with imminently terminal illness: these patients will not benefit from the intervention
3. Does not speak or understand English or French (or unable to communicate): these patients would not be able to complete the study instruments
4. Do not live on the island of Montreal: these patients would be difficult to follow-up

Recruitment start date

01/04/1999

Recruitment end date

31/03/2003

Locations

Countries of recruitment

Canada

Trial participating centre

St Mary's Hospital
Montreal
H3T 1M5
Canada

Sponsor information

Organisation

St Mary's Hospital Center (Canada)

Sponsor details

3830 Lacombe Avenue
Montréal
H3T 1M5
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.smhc.qc.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-15476)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16330624

Publication citations

  1. Results

    Cole MG, McCusker J, Elie M, Dendukuri N, Latimer E, Belzile E, Systematic detection and multidisciplinary care of depression in older medical inpatients: a randomized trial., CMAJ, 2006, 174, 1, 38-44, doi: 10.1503/cmaj.050519.

Additional files

Editorial Notes