Diabetes Mellitus Clinical Trial
— PACE-DOfficial title:
The Patient Activation Through Community Empowerment/Engagement for Diabetes Management (PACE-D) Protocol: A Non-randomised Controlled Trial of Personalised Care and Support Planning for Persons Living With Diabetes
NCT number | NCT04288362 |
Other study ID # | CS-SN-03 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 25, 2019 |
Est. completion date | March 31, 2022 |
Verified date | April 2022 |
Source | National University Health System, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a non-randomised controlled trial involving an intervention group and a control group. It aims to evaluate the effects of a patient engagement and empowerment model of collaborative care support planning on clinical outcomes of patients with diabetes mellitus as compared to usual care in the primary care setting. It also aims will be to examine the impact of the intervention on patient activation, patient and healthcare provider experience, and healthcare utilisation.
Status | Completed |
Enrollment | 1620 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 99 Years |
Eligibility | Inclusion Criteria: - On follow up with an existing teamlet pre-assigned to participate in the study - Adults with diabetes mellitus - Age 21 years and above - Ability to provide informed consent - Ability to communicate in the language(s) which the physician is confident to carry out the care and support planning consult in English, Malay or Chinese - Ability to read and comprehend the Diabetes Results Letter on their own OR has family members who are able to assist to that Exclusion Criteria: - Doctors, Care Managers and Care Coordinators involved in the care and support planning process - Age 21 years and above - Ability to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Polyclinics | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Health System, Singapore | National University Hospital, Singapore, National University, Singapore |
Singapore,
Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. — View Citation
Coulter A, Entwistle VA, Eccles A, Ryan S, Shepperd S, Perera R. Personalised care planning for adults with chronic or long-term health conditions. Cochrane Database Syst Rev. 2015 Mar 3;(3):CD010523. doi: 10.1002/14651858.CD010523.pub2. Review. — View Citation
Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. — View Citation
Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Milbank Q. 1996;74(4):511-44. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in proportion of patients meeting their target blood pressure levels | Change in proportion of patients meeting their target blood pressure levels for patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | |
Other | Change in proportion of patients meeting their target LDL-cholesteterol levels | Change in proportion of patients meeting their target LDL-cholesteterol levels for patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | |
Other | Change in body weight | Change in body weight (kg) in patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | |
Other | Change in exercise duration | Change in exercise duration (minutes per week) in patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | |
Other | Change in smoking rates | Change in smoking rates (cigarettes per day) in patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | |
Other | Change in the proportion (%) of patients who indicate community resource utilisation | Change in the proportion (%) of patients who indicate community resource utilisation in the past 1 year between patients CSP intervention compared with patients receiving standard care. Community resource utilisation history is assessed through dichotomous questionnaire with yes/no response. | From baseline to study endpoint, one year in general | |
Other | Change in Diabetes Foot Screening rates | Change in Diabetes Foot Screening Rates in patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | |
Other | Change in Diabetes Retinal Photography rates | Change in Diabetes Retinal Photography rates in patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | |
Primary | Change in HbA1c levels | Change in HbA1c levels in patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | |
Secondary | Change in mean Patient Activation Measures-13 (PAM-13) scores | Change in mean Patient Activation Measures-13 (PAM-13) scores in patients receiving the CSP intervention compared with patients receiving standard care. PAM-13 is a validated tool with 13-item response rated on a 4-point Likert-type scale that will be converted to a linear score of 0 (lowest patient activation) to 100 (highest patient activation). Higher patient activation score from PAM-13 is associated better healthcare outcomes such as medication adherence. | From baseline to study endpoint, one year in general | |
Secondary | Change in proportion of patients in the various ranges of patient activation levels | Change in proportion of patients in the various ranges of patient activation levels for patients receiving the CSP intervention compared with patients receiving standard care. | From baseline to study endpoint, one year in general | |
Secondary | Change in healthcare utilisation in terms of number of polyclinic visits | Change in healthcare utilisation in terms of number of polyclinic visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | Two years in general from one year preceding recruitment to the period between first and second annual reviews | |
Secondary | Change in healthcare utilisation in terms of proportion (%) of patients with emergency department visits | Change in healthcare utilisation in terms of proportion (%) of patients with emergency department visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | Two years in general from one year preceding recruitment to the period between first and second annual reviews | |
Secondary | Change in healthcare utilisation in terms of number of emergency department visits | Change in healthcare utilisation in terms of number of emergency department visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | Two years in general from one year preceding recruitment to the period between first and second annual reviews | |
Secondary | Change in healthcare utilisation in terms of proportion (%) of patients with hospital inpatient admissions | Change in healthcare utilisation in terms of proportion (%) of patients with hospital inpatient admissions for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | Two years in general from one year preceding recruitment to the period between first and second annual reviews | |
Secondary | Change in healthcare utilisation in terms of number of hospital inpatient admissions | Change in healthcare utilisation in terms of number of hospital inpatient admissions for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | Two years in general from one year preceding recruitment to the period between first and second annual reviews | |
Secondary | Change in healthcare utilisation in terms of proportion (%) of patients with specialist outpatient clinic visits | Change in healthcare utilisation in terms of proportion (%) of patients with specialist outpatient clinic visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | Two years in general from one year preceding recruitment to the period between first and second annual reviews | |
Secondary | Change in healthcare utilisation in terms of number of specialist outpatient clinic visits | Change in healthcare utilisation in terms of number of specialist outpatient clinic visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records. | Two years in general from one year preceding recruitment to the period between first and second annual reviews | |
Secondary | Change in healthcare cost in terms of total healthcare cost of polyclinic, emergency department, hospital admissions and specialist outpatient clinic visits | Change in healthcare cost in terms of total healthcare cost of polyclinic, emergency department, hospital admissions and specialist outpatient clinic visits in patients receiving the CSP intervention compared with patients receiving standard care. | Two years in general from one year preceding recruitment to the period between first and second annual reviews |
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