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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

Integrating Sex and Gender Into CPD for Depression/Diabetes

Clinicaltrials.gov identifier NCT03928132

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted April 26, 2019

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.

  • Condition or Disease:Health Knowledge, Attitudes, Practice
  • Intervention/Treatment: Behavioral: CPD Workshop on Depression and Diabetes
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 90 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: A non-randomized controlled trial
  • Masking: Single (Participant)
  • 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 2017
  • Estimated Primary Completion Date: February 2020
  • Estimated Study Completion Date: March 2020
Arms and interventions
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.
Outcome Measures
  • 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.
Eligibility Criteria
  • 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).

Contacts and Locations
Contacts

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

Locations

Canada, Quebec
CERSSPL
Québec

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

Principal Investigator: France Légaré, MD, PhD CERSSPUL

More Information
  • 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.
  • 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: Continuing professional development
    Diabetes and depression
    Sex and gender
    Continuing medical education
    Minority languages
    Knowledge translation
  • Additional relevant MeSH terms: Depression