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

March 4, 2019 updated by: LMC Diabetes & Endocrinology Ltd.

The Skills, Confidence & Preparedness Index (SCPI) Version 3.0: An Online Version of the SCPI to Evaluate Self-Efficacy of Diabetes Management

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

486

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Barrie, Ontario, Canada
        • LMC Barrie
      • Brampton, Ontario, Canada, L6S 0C9
        • LMC Brampton
      • Etobicoke, Ontario, Canada
        • LMC Etobicoke
      • Oakville, Ontario, Canada
        • LMC Oakville
      • Thornhill, Ontario, Canada
        • LMC Thornhill
      • Toronto, Ontario, Canada, M1R 0B1
        • LMC Scarborough
      • Toronto, Ontario, Canada
        • LMC Bayview

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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%

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.
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 Names:
  • DSME

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24-hours
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.

24-hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

24-hours
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.
one week
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)
24-hours
SCPI completion time
Time Frame: 24-hours
Mean number of minutes it took for patients to complete the SCPI
24-hours
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
3 to 4 months
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
3 to 4 months
Association between total SCPI score and HbA1c
Time Frame: Baseline
Correlation between SCPI score at baseline and HbA1c at baseline in the DSME cohort
Baseline
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
3 to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ronnie Aronson, MD, FRCPC, FACE, LMC Diabetes & Endocrinology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 11, 2017

Primary Completion (ACTUAL)

December 3, 2018

Study Completion (ACTUAL)

December 3, 2018

Study Registration Dates

First Submitted

February 22, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (ACTUAL)

March 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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