NCT03863561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

February 22, 2019

Last Update Submit

March 4, 2019

Conditions

Diabetes Mellitus

Keywords

self-managementquestionnairediabetes education

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • Validity of the SCPI with demographic and diabetes variables

    24-hours

  • Test-retest reliability

    one week

  • Floor/ceiling effect of the total SCPI score

    24-hours

  • SCPI completion time

    24-hours

  • Change in SCPI score

    3 to 4 months

  • +3 more secondary outcomes

Study Arms (2)

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

Interventions

Diabetes self-management education (DSME) programBEHAVIORAL

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.

Also known as: DSME
DSME Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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%

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

LMC Barrie

Barrie, Ontario, Canada

Location

LMC Brampton

Brampton, Ontario, L6S 0C9, Canada

Location

LMC Etobicoke

Etobicoke, Ontario, Canada

Location

LMC Oakville

Oakville, Ontario, Canada

Location

LMC Thornhill

Thornhill, Ontario, Canada

Location

LMC Scarborough

Toronto, Ontario, M1R 0B1, Canada

Location

LMC Bayview

Toronto, Ontario, Canada

Location

Related Publications (5)

  • 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.

    PMID: 28143548BACKGROUND

  • 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.

    PMID: 29097289BACKGROUND

  • 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.

    PMID: 27515966BACKGROUND

  • 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.

    PMID: 25565383BACKGROUND

  • 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.

    PMID: 31399439DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ronnie Aronson, MD, FRCPC, FACE

    LMC Diabetes & Endocrinology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2019

First Posted

March 5, 2019

Study Start

October 11, 2017

Primary Completion

December 3, 2018

Study Completion

December 3, 2018

Last Updated

March 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(7)