An observational study in Diabetes Mellitus, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by The University of Hong Kong · Observational
Diabetes mellitus (DM) is one of the major cause of morbidity and among the top 10 causes of deaths in Hong Kong in 2008 (Department of Health 2009). The Hospital Authority (HA) has initiated service improvement through introducing the risk assessment and management programme (RAMP) to improve the quality of care (QOC) for DM patients in general outpatient clinics (GOPC). The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Department of Family Medicine and Primary Care (FMPC) of the University of Hong Kong (HKU) has been appointed by the HA to carry out the evaluation of the QOC of the programme.
The Action Learning and Audit Spiral methodologies to measure whether the target standard of care intended by the RAMP programme is achieved. Each RAMP participating clinic and hospital will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the RAMP for more than one year will be included in the evaluation on the process and outcomes of care.
One thousand two hundred and forty-eight age and disease matched control patients who have not been enrolled into the RAMP programme will be selected for the comparison in the outcomes of care. A hundred and thirty participants will be followed up by telephone to evaluate the effect of the programme in quality of life (QOL), patient enablement, and global rating of change in health condition at baseline and 6 months after enrolment. Data on the process of care will be retrieved from the HA medical records.
Main Outcome Measures: The primary outcomes are the proportion of participants who have received the criterion process of care, and achieved the target HbA1c and blood pressure levels.
Data Analysis: Descriptive statistics on proportions of centers or subjects meeting the QOC criteria will be calculated. The changes in the clinical and patient reported outcomes of RAMP subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample t-test. The clinical outcomes between RAMP subjects and control group will be compared by independent sample t-test or Chi-square test.
Results: The QOC of the RAMP programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified.
Conclusion: The results of this study will provide empirical evidence on whether the HA's RAMP programme can achieve improvement in QOC for DM patients. The information will be used to guide service planning and policy decision making.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 2,496 is above the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Patients with DM who are mostly independent in their activities of daily living and being followed up at GOPC regularly will be recruited. All enrolled patients will undergo a comprehensive risk assessment and screening for complications, who will then be assigned to receive appropriate interventions and education from multi-disciplinary healthcare professionals according to their risk level. Low risk patients will continue with the usual GOPC follow up, medium risk patients will be given additional intervention by an advanced practice nurse (APN), and high risk patients will be given additional intervention by an APN and an associate consultant (AC) in family medicine (FM).
Exclusion Criteria:
The proportion of clinics that have satisfied each of the structure criteria
Interim analysis will evaluate the period from August, 2009 to December, 2010; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
Time frame: Five years
The proportion of patients who have complied with the criterion process of care.
Interim analysis will evaluate the period from August, 2009 to June, 2011; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
Time frame: Five years
The proportion of patients who have achieved a HbA1c level <7%.
Interim analysis will evaluate the period from August, 2009 to June, 2011; to December, 2011; to December, 2012; to December, 2013. Final analysis will evaluate the period from August, 2009 to December, 2014.
Time frame: Five years
Clinical outcomes including, LDL, BP, body mass index (BMI), and cardiovascular complications.
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.
Time frame: Five years
Patient reported outcomes (PRO) measured by the change in SF-12v2 scores, the PEI and GRS scores at 6 months.
Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.
Time frame: Five years
Service utilization outcomes measured by GOPC consultation, SOPC consultation, A&E and hospital attendance rates in the past 12 months.
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.
Time frame: Five years
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong