Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCT-94830
Study information
Scientific title
Advance planning for health care and research among older adults: a single centre, single-blind randomised controlled trial
Acronym
Study hypothesis
By comparison with a non-exposed control group, does a multimodal professionally-led advance planning intervention stimulating discussion between an older adult and a self-selected proxy about end-of-life care and research participation, and including an educational component on advance directives (ADs) improve the accuracy of substitute decision-making and increase the frequency of written ADs for health care and research?
Ethics approval
Local medical ethics committee (comité d'éthique de la recherche sur le vieillissement du Centre de santé et de services sociaux - Institut universitaire de gériatrie de Sherbrooke [CSSS-IUGS]) approved on the 7th July 2009 (ref: 2009-12)
Study design
Single centre single-blind stratified randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Advance directives for health care and research
Intervention
Experimental group:
One- to two-hour meetings once monthly over three months. First and third meetings will be with trained social workers, at the home of the older adult or proxy. Second meeting will be a group information session on ADs at the research centre, conducted by three co-investigators with expertise in health law, decisional incapacity and end-of-life care. At the first home visit, there will be discussion of vignettes highlighting importance of communicating one's wishes about future medical care and research participation. At third and last meeting, understanding of the information delivered at second meeting will be checked.
Control group:
One- to two-hour group educational seminars held once a month over three months, about preventive health practices.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Prediction accuracy of substitute decision-making. Concordance assessments will be measured at 3 months and 12 months after the end of the intervention, using the same procedure as at baseline.
Secondary outcome measures
Rates of written ADs. Three months and 12 months post-intervention, participants will be asked whether they have indicated their healthcare and/or research preferences in writing.
Overall trial start date
01/10/2009
Overall trial end date
01/02/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Community-dwelling French-speaking individuals
2. Aged 70 years and over, either sex
3. Living in the Sherbrooke area in the province of Quebec
4. No cognitive deficits
5. Agree to designate a potential French-speaking proxy living in the same area
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
240 dyads
Total final enrolment
470
Participant exclusion criteria
1. Mental disorders (International Classification of Diseases, 9th Edition [ICD-9], section 5)
2. Some diseases of the nervous system and sense organs (ICD-9, section 6)
3. Deafness
4. Blindness
5. Alcoholism
Recruitment start date
01/10/2009
Recruitment end date
01/02/2011
Locations
Countries of recruitment
Canada
Trial participating centre
Research Centre on Aging
Sherbrooke
J1H 4C4
Canada
Sponsor information
Organisation
Research Centre on Aging (Canada)
Sponsor details
Sherbrooke University Institute of Geriatrics
1036 South Belvedere Street
Sherbrooke QC
J1H 4C4
Canada
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-94830)
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
Basic results (scientific)
Publication list
2012 protocol in https://pubmed.ncbi.nlm.nih.gov/22221980/ (added 29/12/2020)
2017 results in https://pubmed.ncbi.nlm.nih.gov/28260547/ (added 29/12/2020)
2018 results in https://pubmed.ncbi.nlm.nih.gov/29523757/ (added 29/12/2020)