Chronic Care Management/Patient Relationship Management Proof of Concept
| Tracking Information | |||||
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| First Received Date ICMJE | August 11, 2010 | ||||
| Last Updated Date | August 12, 2010 | ||||
| Start Date ICMJE | May 2010 | ||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Technology engagement [ Time Frame: 3 months ] [ Designated as safety issue: No ] Assessment of program feasibility by patient engagement and satisfaction with the technology-based intervention. Measured by analysis of response rates and average response times to medical requests and appointment reminders, and by content analysis of patient survey and focus group data. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01182480 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chronic Care Management/Patient Relationship Management Proof of Concept | ||||
| Official Title ICMJE | Chronic Care Management/Patient Relationship Management Proof of Concept | ||||
| Brief Summary | This proof of concept study proposes to evaluate the feasibility of a communications-technology-based chronic care and patient relationship management program to improve diabetes self management among adult diabetic patients in an urban safety net population by providing between-visit reminders and chronic disease support through cell phone text messaging. The investigators hypothesize that diabetic patients enrolled in the program will be less likely to miss scheduled appointments and will have greater perceived self-efficacy and improved patient satisfaction concerning chronic disease management. No-show rates among patients enrolled in the program are expected to be lower than among patients receiving standard care. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Diabetes Mellitus | ||||
| Intervention ICMJE | Behavioral: Patient Relationship Management (PRM) Program
Patients will be contacted through SMS text messaging under the following circumstances:
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | November 2010 | ||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 76 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01182480 | ||||
| Other Study ID Numbers ICMJE | COMIRB 10-0257 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Andrew W. Steele, MD, MPH, MSc, Denver Health and Hospital Authority | ||||
| Study Sponsor ICMJE | Denver Health and Hospital Authority | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Denver Health and Hospital Authority | ||||
| Verification Date | July 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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