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Integrating Sex and Gender Into CPD for Depression/Diabetes (INCluDED)

Primary Purpose

Health Knowledge, Attitudes, Practice

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CPD Workshop on Depression and Diabetes
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Health Knowledge, Attitudes, Practice focused on measuring Diabetes and depression, Continuing professional development, Continuing medical education, Sex and gender, Minority languages, Knowledge translation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • CERSSPL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

CPD Workshop on Depression and Diabetes

CPD Workshop on Depression and Diabetes II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Acceptability Questionnaire
1) Participants rate acceptability of workshop with the following 9 items: organization, clarity, mastery of subject by trainer, exercises and discussion, presentation of sex and gender data, group interaction, overall quality, organization and quality of discussions and presentations, quality of documents distributed (Poor, Acceptable, Good, Very Good, or Excellent); 2) Participants rate the workshop length (too short, just right, too long); 3) Participants rate their confidence in incorporating the notions presented in the workshop in their management of Type 2 Diabetes (with or without depression) (scale of 1-10, 1=very little confidence, 10=very confident) both before and after the workshop; 4) Participants describe what changes they will make in their practice following the workshop; 5) Participants describe what they liked most and 6) least about the workshop; 7) Participants are asked if they thought the presentation was biased (yes/no) and if yes, are asked for details.

Full Information

First Posted
April 23, 2019
Last Updated
February 10, 2021
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Institutes of Health Research (CIHR), Chaire Claire-Bonenfant-Femmes, Savoir et Société, Institut du Savoir Montfort
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1. Study Identification

Unique Protocol Identification Number
NCT03928132
Brief Title
Integrating Sex and Gender Into CPD for Depression/Diabetes
Acronym
INCluDED
Official Title
Integrating Sex and Gender Considerations Into a Continuing Professional Development Activity on Diabetes and Depression: Protocol for a Non-Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
July 23, 2020 (Actual)
Study Completion Date
July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Institutes of Health Research (CIHR), Chaire Claire-Bonenfant-Femmes, Savoir et Société, Institut du Savoir Montfort

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Knowledge, Attitudes, Practice
Keywords
Diabetes and depression, Continuing professional development, Continuing medical education, Sex and gender, Minority languages, Knowledge translation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A non-randomized controlled trial
Masking
Participant
Masking Description
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).
Allocation
Non-Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPD Workshop on Depression and Diabetes
Arm Type
Experimental
Arm Description
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.
Arm Title
CPD Workshop on Depression and Diabetes II
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CPD Workshop on Depression and Diabetes
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immediate clinical behavioural intention, as measured by CPD-REACTION questionnaire
Description
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.
Time Frame
Immediately following the intervention
Title
Change from immediate clinical behavioural intention at 3 months, as measured by CPD-REACTION questionnaire
Description
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.
Time Frame
3 months after the intervention
Secondary Outcome Measure Information:
Title
Acceptability Questionnaire
Description
1) Participants rate acceptability of workshop with the following 9 items: organization, clarity, mastery of subject by trainer, exercises and discussion, presentation of sex and gender data, group interaction, overall quality, organization and quality of discussions and presentations, quality of documents distributed (Poor, Acceptable, Good, Very Good, or Excellent); 2) Participants rate the workshop length (too short, just right, too long); 3) Participants rate their confidence in incorporating the notions presented in the workshop in their management of Type 2 Diabetes (with or without depression) (scale of 1-10, 1=very little confidence, 10=very confident) both before and after the workshop; 4) Participants describe what changes they will make in their practice following the workshop; 5) Participants describe what they liked most and 6) least about the workshop; 7) Participants are asked if they thought the presentation was biased (yes/no) and if yes, are asked for details.
Time Frame
Immediately following the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: French-speaking health professionals (in practice and in training).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
France Légaré, MD, PhD
Organizational Affiliation
CERSSPUL
Official's Role
Principal Investigator
Facility Information:
Facility Name
CERSSPL
City
Québec
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate anonymous data only in the form of published results.
Citations:
PubMed Identifier
35459660
Citation
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.
Results Reference
derived

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Integrating Sex and Gender Into CPD for Depression/Diabetes

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