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The Skills, Confidence & Preparedness Index (SCPI) (SCPI)

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ClinicalTrials.gov Identifier: NCT03863561
Recruitment Status : Completed
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
LMC Diabetes & Endocrinology Ltd.

Brief Summary:
The LMC Skills, Confidence and Preparedness Index (SCPI) is a tool that was developed by diabetes specialists to individualize the education/support that a healthcare provider delivers to patients with diabetes. It has been shown to have high reliability, validity and generalizability. This study assessed the validity and reliability of a revised, final version of the SCPI in a large sample of patients with type 1 and type 2 diabetes, as well as the clinical responsiveness of the SCPI to a diabetes self-management education intervention in a smaller cohort of patients with poor glycemic control.

Condition or disease Intervention/treatment
Diabetes Mellitus Behavioral: Diabetes self-management education (DSME) program

Detailed Description:

Canadian experts in diabetes care developed the Skills, Confidence & Preparedness Index (SCPI) to assess diabetes self-management in patients. The SCPI is web-based, gives immediate feedback to the healthcare provider, and is associated with glycemia. The SCPI was designed to allow a healthcare provider to individualize the education/support by assessing the three critical dimensions of self-management: knowledge of a skill; confidence in ability to change a behavior; and preparedness to begin implementing the behavior change. Two previous validation studies showed that the SCPI has high internal consistency, reliability, generalizability, and external validity.

Following further focus groups with healthcare providers and patients, the SCPI questions and response scale were edited to further optimize clarity. This study assessed the validity and reliability of a revised, final version of the LMC SCPI in a large sample of diabetes patients, as well as clinical responsiveness of the SCPI to a diabetes self-management education (DSME) program intervention.

This study recruited type 1 and type 2 patients from the waiting rooms of seven LMC Diabetes & Endocrinology specialist clinics in Ontario, Canada. Patients completed the SCPI electronically and their demographic and health information was retrieved from their electronic medical records. A smaller cohort of patients with uncontrolled glycemia were enrolled into a DSME program. Participants completed the SCPI at their baseline visit and their individual results were incorporated into the care paths that were then customized for that participant. The DSME program provided five to seven visits with a diabetes educator over three to four months. Patients completed the SCPI again at their final visit.


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Study Type : Observational
Actual Enrollment : 486 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Skills, Confidence & Preparedness Index (SCPI) Version 3.0: An Online Version of the SCPI to Evaluate Self-Efficacy of Diabetes Management
Actual Study Start Date : October 11, 2017
Actual Primary Completion Date : December 3, 2018
Actual Study Completion Date : December 3, 2018

Group/Cohort Intervention/treatment
Waiting room sample
Patients with type 1 or type 2 diabetes attending an LMC Diabetes & Endocrinology specialist clinic in Ontario completed the SCPI in the waiting room while attending their usual appointment with their healthcare provider.
DSME Intervention
Patients with poor glycemic control (A1C >8.0%) were enrolled into a diabetes self-management education (DSME) program. The SCPI was completed at their first and last visit and and their individual results were incorporated into the care paths that were then customized for that participant. The patient met with a diabetes educator five to seven times over the course of three to four months.
Behavioral: Diabetes self-management education (DSME) program
Diabetes educators customized care paths for their patients based on their individual responses to the SCPI questions. Patients met with an educator five to seven times over the course of three to four months.
Other Name: DSME




Primary Outcome Measures :
  1. Internal consistency of the SCPI (Skills, Confidence & Preparedness Index) [ Time Frame: 24-hours ]
    Cronbach's alpha score for the total SCPI score (minimum score 1, maximum score 7) and the three subscales (minimum score 1, maximum score 7) in the waiting room sample. A higher score indicates greater diabetes self-management.

  2. Validity of the SCPI with HbA1c [ Time Frame: 24-hours ]

    Correlation between the total SCPI score (minimum score 1, maximum score 7) and the three subscale scores (minimum score 1, maximum score 7) with HbA1c in the waiting room sample.

    A higher SCPI score indicates greater diabetes self-management.



Secondary Outcome Measures :
  1. Validity of the SCPI with demographic and diabetes variables [ Time Frame: 24-hours ]

    Correlation between the total SCPI score (minimum score 1, maximum score 7) and age, gender, education, ethnicity, duration of diabetes and diabetes therapy in the waiting room sample.

    A higher SCPI score indicates greater diabetes self-management.


  2. Test-retest reliability [ Time Frame: one week ]
    Applicable to patients from the waiting room sample who completed the SCPI in the clinic and again one week later. Correlation between the first total SCPI score (minimum score 1, maximum score 7) and the second total SCPI scores.

  3. Floor/ceiling effect of the total SCPI score [ Time Frame: 24-hours ]
    Assessment of a floor effect (>15% of patients with a minimum score of 1) or a ceiling effect (>15% of patients with a maximum score of 7)

  4. SCPI completion time [ Time Frame: 24-hours ]
    Mean number of minutes it took for patients to complete the SCPI

  5. Change in SCPI score [ Time Frame: 3 to 4 months ]
    Mean change in SCPI total score between the baseline visit and follow-up visit in the DSME cohort

  6. Change in HbA1c [ Time Frame: 3 to 4 months ]
    Mean change in HbA1c between the baseline visit and the follow-up visit in the DSME cohort

  7. Association between total SCPI score and HbA1c [ Time Frame: Baseline ]
    Correlation between SCPI score at baseline and HbA1c at baseline in the DSME cohort

  8. Responsiveness of the total SCPI score to an intervention [ Time Frame: 3 to 4 months ]
    Correlation between change in SCPI score and change in HbA1c in the DSME cohort



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Waiting room cohort: adult patients with type 1 or type 2 diabetes attending their usual visit with their LMC healthcare provider

DSME cohort: patients with type 1 or type 2 diabetes with a recent A1C ≥ 8.0%

Criteria

Inclusion Criteria:

  • Diagnosis of type 1 or type 2 diabetes
  • Age ≥ 18 years
  • Ability to read English
  • Duration of diabetes ≥ 6 months (DSME cohort only)
  • A1C ≥ 8.0% (DSME cohort only)

Exclusion Criteria:


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): NCT03863561


Locations
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Canada, Ontario
LMC Barrie
Barrie, Ontario, Canada
LMC Brampton
Brampton, Ontario, Canada, L6S 0C9
LMC Etobicoke
Etobicoke, Ontario, Canada
LMC Oakville
Oakville, Ontario, Canada
LMC Thornhill
Thornhill, Ontario, Canada
LMC Scarborough
Toronto, Ontario, Canada, M1R 0B1
LMC Bayview
Toronto, Ontario, Canada
Sponsors and Collaborators
LMC Diabetes & Endocrinology Ltd.
Investigators
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Principal Investigator: Ronnie Aronson, MD, FRCPC, FACE LMC Diabetes & Endocrinology

Publications:
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Responsible Party: LMC Diabetes & Endocrinology Ltd.
ClinicalTrials.gov Identifier: NCT03863561     History of Changes
Other Study ID Numbers: SCPI
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 LMC Diabetes & Endocrinology Ltd.:
self-management
questionnaire
diabetes education

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases