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

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ClinicalTrials.gov Identifier: NCT03928132
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Chaire Claire-Bonenfant-Femmes, Savoir et Société
Institut du Savoir Montfort
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

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.


Condition or disease Intervention/treatment Phase
Health Knowledge, Attitudes, Practice Behavioral: CPD Workshop on Depression and Diabetes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A non-randomized controlled trial
Masking: Single (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).
Primary Purpose: Health Services Research
Official Title: Integrating Sex and Gender Considerations Into a Continuing Professional Development Activity on Diabetes and Depression: Protocol for a Non-Randomized Controlled Trial
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CPD Workshop on Depression and Diabetes
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
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.

Sham Comparator: CPD Workshop on Depression and Diabetes II
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
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 Measures :
  1. Immediate clinical behavioural intention, as measured by CPD-REACTION questionnaire [ Time Frame: Immediately following the intervention ]
    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.

  2. Change from immediate clinical behavioural intention at 3 months, as measured by CPD-REACTION questionnaire [ Time Frame: 3 months after the intervention ]
    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 :
  1. Acceptability Questionnaire [ Time Frame: Immediately following the intervention. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928132


Contacts
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Contact: France Légaré, MD, PhD +1 (418) 821-9481 france.legare@fmed.ulaval.ca

Locations
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Canada, Quebec
CERSSPL Recruiting
Québec, Quebec, Canada
Contact: France Légaré, MD, PhD         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Institutes of Health Research (CIHR)
Chaire Claire-Bonenfant-Femmes, Savoir et Société
Institut du Savoir Montfort
Investigators
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Principal Investigator: France Légaré, MD, PhD CERSSPUL

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Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03928132     History of Changes
Other Study ID Numbers: 384530
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Aggregate anonymous data only in the form of published results.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Quebec-Universite Laval:
Diabetes and depression
Continuing professional development
Continuing medical education
Sex and gender
Minority languages
Knowledge translation

Additional relevant MeSH terms:
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Depression
Behavioral Symptoms