Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT03863561
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2019-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Skills, Confidence & Preparedness Index (SCPI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-04', 'studyFirstSubmitDate': '2019-02-22', 'studyFirstSubmitQcDate': '2019-03-04', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Internal consistency of the SCPI (Skills, Confidence & Preparedness Index)', 'timeFrame': '24-hours', 'description': "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."}, {'measure': 'Validity of the SCPI with HbA1c', 'timeFrame': '24-hours', 'description': '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.\n\nA higher SCPI score indicates greater diabetes self-management.'}], 'secondaryOutcomes': [{'measure': 'Validity of the SCPI with demographic and diabetes variables', 'timeFrame': '24-hours', 'description': '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.\n\nA higher SCPI score indicates greater diabetes self-management.'}, {'measure': 'Test-retest reliability', 'timeFrame': 'one week', 'description': '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.'}, {'measure': 'Floor/ceiling effect of the total SCPI score', 'timeFrame': '24-hours', 'description': '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)'}, {'measure': 'SCPI completion time', 'timeFrame': '24-hours', 'description': 'Mean number of minutes it took for patients to complete the SCPI'}, {'measure': 'Change in SCPI score', 'timeFrame': '3 to 4 months', 'description': 'Mean change in SCPI total score between the baseline visit and follow-up visit in the DSME cohort'}, {'measure': 'Change in HbA1c', 'timeFrame': '3 to 4 months', 'description': 'Mean change in HbA1c between the baseline visit and the follow-up visit in the DSME cohort'}, {'measure': 'Association between total SCPI score and HbA1c', 'timeFrame': 'Baseline', 'description': 'Correlation between SCPI score at baseline and HbA1c at baseline in the DSME cohort'}, {'measure': 'Responsiveness of the total SCPI score to an intervention', 'timeFrame': '3 to 4 months', 'description': 'Correlation between change in SCPI score and change in HbA1c in the DSME cohort'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['self-management', 'questionnaire', 'diabetes education'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '28143548', 'type': 'BACKGROUND', '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.'}, {'pmid': '29097289', 'type': 'BACKGROUND', '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.'}, {'pmid': '27515966', 'type': 'BACKGROUND', '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.'}, {'pmid': '25565383', 'type': 'BACKGROUND', '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.'}, {'pmid': '31399439', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nFollowing 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Waiting room cohort: adult patients with type 1 or type 2 diabetes attending their usual visit with their LMC healthcare provider\n\nDSME cohort: patients with type 1 or type 2 diabetes with a recent A1C ≥ 8.0%', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 1 or type 2 diabetes\n* Age ≥ 18 years\n* Ability to read English\n* Duration of diabetes ≥ 6 months (DSME cohort only)\n* A1C ≥ 8.0% (DSME cohort only)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03863561', 'acronym': 'SCPI', 'briefTitle': 'The Skills, Confidence & Preparedness Index (SCPI)', 'organization': {'class': 'OTHER', 'fullName': 'LMC Diabetes & Endocrinology Ltd.'}, 'officialTitle': 'The Skills, Confidence & Preparedness Index (SCPI) Version 3.0: An Online Version of the SCPI to Evaluate Self-Efficacy of Diabetes Management', 'orgStudyIdInfo': {'id': 'SCPI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Waiting room sample', 'description': '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.'}, {'label': 'DSME Intervention', 'description': '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.', 'interventionNames': ['Behavioral: Diabetes self-management education (DSME) program']}], 'interventions': [{'name': 'Diabetes self-management education (DSME) program', 'type': 'BEHAVIORAL', 'otherNames': ['DSME'], 'description': '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.', 'armGroupLabels': ['DSME Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Barrie', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L6S 0C9', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Brampton', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'city': 'Etobicoke', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Etobicoke', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Oakville', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'city': 'Thornhill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Thornhill', 'geoPoint': {'lat': 43.80011, 'lon': -79.4163}}, {'zip': 'M1R 0B1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Scarborough', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'LMC Bayview', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Ronnie Aronson, MD, FRCPC, FACE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LMC Diabetes & Endocrinology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMC Diabetes & Endocrinology Ltd.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}