Condition category
Not Applicable
Date applied
10/08/2009
Date assigned
20/08/2009
Last edited
20/08/2009
Prospective/Retrospective
Prospectively 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

Prof Gina Bravo

ORCID ID

Contact details

Research Centre on Aging
1036 South Belvedere Street
Sherbrooke
J1H 4C4
Canada

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 measures

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

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

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

http://www.csss-iugs.ca/cdrv

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes