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NCT Number: NCT03863561

The Skills, Confidence & Preparedness Index (SCPI)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LMC Barrie, Barrie, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Diabetes self-management education (DSME) program

Behavioral

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.

Other names: DSME

Primary outcomes

  1. Internal consistency of the SCPI (Skills, Confidence & Preparedness Index)

    Time frame: 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.

  2. Validity of the SCPI with HbA1c

    Time frame: 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 outcomes

  1. Validity of the SCPI with demographic and diabetes variables

    Time frame: 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.

  2. Test-retest reliability

    Time frame: 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.

  3. Floor/ceiling effect of the total SCPI score

    Time frame: 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)

  4. SCPI completion time

    Time frame: 24-hours

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

  5. Change in SCPI score

    Time frame: 3 to 4 months

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

  6. Change in HbA1c

    Time frame: 3 to 4 months

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

  7. Association between total SCPI score and HbA1c

    Time frame: Baseline

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

  8. Responsiveness of the total SCPI score to an intervention

    Time frame: 3 to 4 months

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

Sponsors and collaborators

Lead sponsor

LMC Diabetes & Endocrinology Ltd.

Other

Registry information

Official study title

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

Acronym: SCPI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 5, 2019
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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