NCT03928132

Brief Summary

People with type 2 diabetes are twice as likely to experience depression as nondiabetic individuals, and depression in turn increases the risk of diabetes. Clinical care for patients for either condition usually fails to consider the impact of sex and gender on tests, diagnosis and treatment, and evidence on these impacts is limited. The investigators aim to assess the impact of a continuing professional education activity (CPD) on diabetes and depression that includes considerations of sex and gender on the clinical behaviours of French-speaking healthcare professionals in Canada. In a non-randomised controlled trial, the investigators are assessing the impacts of two CPD activities on depression and diabetes, one that includes considerations of sex and gender, and an identical one that omits sex and gender considerations, on French-speaking healthcare professionals' self-reported clinical behaviors regarding sex and gender considerations post-intervention and at 3 months. Data collection will occur in three distinct locations in Canada. Project development, data collection and analysis and dissemination of results will all integrate considerations of sex and gender. The process of creating a CPD activity that integrates considerations of sex and gender could be scaled up to other CPD activities in other clinical subjects and in other minority languages.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2020

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

3.3 years

First QC Date

April 23, 2019

Last Update Submit

February 10, 2021

Conditions

Keywords

Diabetes and depressionContinuing professional developmentContinuing medical educationSex and genderMinority languagesKnowledge translation

Outcome Measures

Primary Outcomes (2)

  • Immediate clinical behavioural intention, as measured by CPD-REACTION questionnaire

    Clinical behavioural intention to integrate considerations of sex and gender into the diagnosis and treatment of depression and diabetes, using the validated CPD-REACTION scale. CPD=continuing professional development, REACTION=a theoRy-basEd instrument to assess the impACT of continuing professional development activities on professional behavIOr chaNge. A 12-item Likert-type scale (i.e., Strongly disagree = 1, Strongly agree = 7; Never = 1, Always = 7, etc.) evaluates 5 constructs: 1) intention; 2) social influence; 3) beliefs about capabilities; 4) moral norms; and 5) beliefs about consequences. Sociodemographic questions are asked on sex, age (10 age ranges), province, rural/urban/semi-rural practice, and language of consultation. Mean, standard deviation, median and frequencies are calculated to summarize participant characteristics and questionnaire item responses. Construct scores are obtained by calculating the mean score for the items.

    Immediately following the intervention

  • Change from immediate clinical behavioural intention at 3 months, as measured by CPD-REACTION questionnaire

    Evolution of clinical behavioural intention to integrate considerations of sex and gender into the diagnosis and treatment of depression and diabetes, using the validated CPD-REACTION scale, after a 3-month period.

    3 months after the intervention

Secondary Outcomes (1)

  • Acceptability Questionnaire

    Immediately following the intervention.

Study Arms (2)

CPD Workshop on Depression and Diabetes

EXPERIMENTAL

Participants in this arm will take part in a clinical CPD activity on depression and diabetes. The activity will include considerations of sex and gender, e.g. the different risk factors and impacts of treatment among women and men.

Behavioral: CPD Workshop on Depression and Diabetes

CPD Workshop on Depression and Diabetes II

SHAM COMPARATOR

Participants in this arm will take part in a clinical CPD activity on depression and diabetes. The activity will exclude considerations of sex and gender, e.g. the different risk factors and impacts of treatment among women and men.

Behavioral: CPD Workshop on Depression and Diabetes

Interventions

2 parallel face-to-face onsite workshops on diabetes and depression in primary care given by experts in French (control and experimental) using Powerpoint presentations.

CPD Workshop on Depression and DiabetesCPD Workshop on Depression and Diabetes II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • French-speaking health professionals (in practice and in training).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CERSSPL

Québec, Quebec, Canada

Location

Related Publications (1)

  • Deom Tardif A, Gogovor A, Guay-Belanger S, Audet D, Parent N, Gaudreau A, Remy-Lamarche D, Vigneault L, Ngueta G, Bilodeau A, Legare F; mATrICES-F Group. Integration of sex and gender in a continuing professional development course on diabetes and depression: a mixed methods feasibility study. BMJ Open. 2022 Apr 22;12(4):e050890. doi: 10.1136/bmjopen-2021-050890.

MeSH Terms

Conditions

BehaviorDiabetes MellitusDepressionCoitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavioral SymptomsSexual Behavior

Study Officials

  • France Légaré, MD, PhD

    CERSSPUL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Health professionals will self-select their attendance at one or other of the interventions (control or experimental CPD activity) without knowing that they are different (one including sex and gender considerations, the other excluding them).
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A non-randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 25, 2019

Study Start

April 1, 2017

Primary Completion

July 23, 2020

Study Completion

July 23, 2020

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Aggregate anonymous data only in the form of published results.

Locations