The Skills, Confidence & Preparedness Index (SCPI)

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Diabetes self-management education (DSME) program

• Registration Number: NCT03863561
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-10-11
• Primary Completion: 2018-12-03
• Study Completion: 2018-12-03
• Study First Submitted: 2019-02-22
• Status Verified: 2019-03
• Study First Submitted QC: 2019-03-04
• Last Update Submitted: 2019-03-04
• Study First Posted: 2019-03-05
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 486

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DSME Intervention	Diabetes self-management education (DSME) program	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.

Primary Outcome Measures

Name	Time	Method
Internal consistency of the SCPI (Skills, Confidence & Preparedness Index)	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.
Validity of the SCPI with HbA1c	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

Name	Time	Method
Test-retest reliability	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.
Change in SCPI score	3 to 4 months	Mean change in SCPI total score between the baseline visit and follow-up visit in the DSME cohort
Change in HbA1c	3 to 4 months	Mean change in HbA1c between the baseline visit and the follow-up visit in the DSME cohort
Responsiveness of the total SCPI score to an intervention	3 to 4 months	Correlation between change in SCPI score and change in HbA1c in the DSME cohort
Validity of the SCPI with demographic and diabetes variables	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.
Association between total SCPI score and HbA1c	Baseline	Correlation between SCPI score at baseline and HbA1c at baseline in the DSME cohort
SCPI completion time	24-hours	Mean number of minutes it took for patients to complete the SCPI
Floor/ceiling effect of the total SCPI score	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)

Trial Locations

Locations (7)

LMC Barrie; 🇨🇦 Barrie, Ontario, Canada

LMC Brampton; 🇨🇦 Brampton, Ontario, Canada

LMC Etobicoke; 🇨🇦 Etobicoke, Ontario, Canada

LMC Oakville; 🇨🇦 Oakville, Ontario, Canada

LMC Thornhill; 🇨🇦 Thornhill, Ontario, Canada

LMC Scarborough; 🇨🇦 Toronto, Ontario, Canada

LMC Bayview; 🇨🇦 Toronto, Ontario, Canada