Clinical trial NCT03863561: The Skills, Confidence & Preparedness Index (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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: self-management
questionnaire
diabetes education
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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%

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.

Eligibility 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:

-

Primary outcomes:
measure: Internal consistency of the SCPI (Skills, Confidence & Preparedness Index)
timeFrame: 24-hours
measure: Validity of the SCPI with HbA1c
timeFrame: 24-hours
Secondary outcomes:
measure: Validity of the SCPI with demographic and diabetes variables
timeFrame: 24-hours
measure: Test-retest reliability
timeFrame: one week
measure: Floor/ceiling effect of the total SCPI score
timeFrame: 24-hours
measure: SCPI completion time
timeFrame: 24-hours
measure: Change in SCPI score
timeFrame: 3 to 4 months
measure: Change in HbA1c
timeFrame: 3 to 4 months
measure: Association between total SCPI score and HbA1c
timeFrame: Baseline
measure: Responsiveness of the total SCPI score to an intervention
timeFrame: 3 to 4 months
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: LMC Barrie
state: Ontario
city: Brampton
country: Canada
facility: LMC Brampton
state: Ontario
city: Etobicoke
country: Canada
facility: LMC Etobicoke
state: Ontario
city: Oakville
country: Canada
facility: LMC Oakville
state: Ontario
city: Thornhill
country: Canada
facility: LMC Thornhill
state: Ontario
city: Toronto
country: Canada
facility: LMC Scarborough
state: Ontario
city: Toronto
country: Canada
facility: LMC Bayview
state: Ontario
Study officials:
affiliation: LMC Diabetes & Endocrinology
name: Ronnie Aronson, MD, FRCPC, FACE
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
citation: Aronson R, Li A, Brown RE, Walker A, Lyons A, Orzech N. Optimizing Diabetes Self-management Using the Novel Skills, Confidence, and Preparedness Index (SCPI). Diabetes Care. 2019 Oct;42(10):1873-1878. doi: 10.2337/dc19-0699. Epub 2019 Aug 9.