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AzTrials

Diabetes MellitusSCPINCT03863561

The Skills, Confidence & Preparedness Index (SCPI)

An observational study of Diabetes Mellitus, run by LMC Diabetes & Endocrinology Ltd. at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
Diabetes self-management education (DSME) program
How many people
486 participants
Where
7 sitesCanada
Study dates
11 Oct 2017to 3 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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%

Who may be able to join

  • 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)

Who cannot join

  • -

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • LMC Barrie

    Barrie, Ontario

  • LMC Brampton

    Brampton, Ontario, L6S 0C9

  • LMC Etobicoke

    Etobicoke, Ontario

  • LMC Oakville

    Oakville, Ontario

  • LMC Thornhill

    Thornhill, Ontario

  • LMC Scarborough

    Toronto, Ontario, M1R 0B1

  • LMC Bayview

    Toronto, Ontario

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Diabetes self-management education (DSME) program
Keywords
self-management, questionnaire, diabetes education
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes self-management education (DSME) programBehavioural

    Also called DSME

    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.

Study groups in NCT03863561
Study groupRoleWhat they receive
Waiting room samplePatients 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 InterventionPatients 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.
Receives: Behavioral: Diabetes self-management education (DSME) program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24-hours

  2. 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.

    Measured: 24-hours

Secondary outcomes (8)

  1. 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.

    Measured: 24-hours

  2. 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.

    Measured: one week

  3. 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)

    Measured: 24-hours

  4. SCPI completion time

    Mean number of minutes it took for patients to complete the SCPI

    Measured: 24-hours

  5. Change in SCPI score

    Mean change in SCPI total score between the baseline visit and follow-up visit in the DSME cohort

    Measured: 3 to 4 months

  6. Change in HbA1c

    Mean change in HbA1c between the baseline visit and the follow-up visit in the DSME cohort

    Measured: 3 to 4 months

  7. Association between total SCPI score and HbA1c

    Correlation between SCPI score at baseline and HbA1c at baseline in the DSME cohort

    Measured: Baseline

  8. Responsiveness of the total SCPI score to an intervention

    Correlation between change in SCPI score and change in HbA1c in the DSME cohort

    Measured: 3 to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2019
  2. Study start11 Oct 2017
  3. Primary completion3 Dec 2018
  4. Study completion3 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03863561
Sponsor's protocol ID
SCPI
Acronym
SCPI
Status last verified
Mar 2019
First submitted
22 Feb 2019
Last updated
5 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28143548

  • 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.

    PubMed 29097289

  • 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.

    PubMed 27515966

  • 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.

    PubMed 25565383

  • 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.

    PubMed 31399439

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by LMC Diabetes & Endocrinology Ltd. at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Internal consistency of the SCPI (Skills, Confidence & Preparedness Index) (time frame: 24-hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03863561, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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