The Skills, Confidence & Preparedness Index (SCPI)

Diabetes Mellitus Clinical Trial

— SCPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863561
• Other study ID #: SCPI
• Status: Completed
• Start date: October 11, 2017
• Est. completion date: December 3, 2018

Study information

• Verified date: March 2019
• Source: LMC Diabetes & Endocrinology Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: December 3, 2018
• Est. primary completion date: December 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Canada	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 Bayview	Toronto	Ontario
Canada	LMC Scarborough	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
LMC Diabetes & Endocrinology Ltd.

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Aronson R, Brown RE, Jiandani D, Walker A, Orzech N, Mbuagbaw L. Assessment of self-management in patients with diabetes using the novel LMC Skills, Confidence and Preparedness Index (SCPI). Diabetes Res Clin Pract. 2018 Mar;137:128-136. doi: 10.1016/j.diabres.2017.10.028. Epub 2017 Oct 31. — View Citation

Aronson R, Orzech N, Ye C, Brown RE, Goldenberg R, Brown V. Specialist-Led Diabetes Registries and Prevalence of Poor Glycemic Control in Type 2 Diabetes: The Diabetes Registry Outcomes Project for A1C Reduction (DROP A1C). Diabetes Care. 2016 Oct;39(10):1711-7. doi: 10.2337/dc15-2666. Epub 2016 Aug 11. — View Citation

Aronson R, Orzech N, Ye C, Goldenberg R, Brown V. Specialist-led diabetes registries and predictors of poor glycemic control in type 2 diabetes: Insights into the functionally refractory patient from the LMC Diabetes Registry database. J Diabetes. 2016 Jan;8(1):76-85. doi: 10.1111/1753-0407.12257. Epub 2015 Mar 24. — View Citation

Mbuagbaw L, Aronson R, Walker A, Brown RE, Orzech N. The LMC Skills, Confidence & Preparedness Index (SCPI): development and evaluation of a novel tool for assessing self-management in patients with diabetes. Health Qual Life Outcomes. 2017 Jan 31;15(1):27. doi: 10.1186/s12955-017-0606-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Internal consistency of the SCPI (Skills, Confidence & Preparedness Index)	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
Primary	Validity of the SCPI with HbA1c	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	Validity of the SCPI with demographic and diabetes variables	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
Secondary	Test-retest reliability	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
Secondary	Floor/ceiling effect of the total SCPI score	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
Secondary	SCPI completion time	Mean number of minutes it took for patients to complete the SCPI	24-hours
Secondary	Change in SCPI score	Mean change in SCPI total score between the baseline visit and follow-up visit in the DSME cohort	3 to 4 months
Secondary	Change in HbA1c	Mean change in HbA1c between the baseline visit and the follow-up visit in the DSME cohort	3 to 4 months
Secondary	Association between total SCPI score and HbA1c	Correlation between SCPI score at baseline and HbA1c at baseline in the DSME cohort	Baseline
Secondary	Responsiveness of the total SCPI score to an intervention	Correlation between change in SCPI score and change in HbA1c in the DSME cohort	3 to 4 months