Diabetes MellitusQoC PEPNCT01935349
Evaluation of Quality of Care - Patient Empowerment Programme, HA
An observational study of Diabetes Mellitus and Hypertension, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Diabetes mellitus (DM) and hypertension (HT) are major causes 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 patient empowerment programme (PEP) to improve the quality of care… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- How many people
- 2,496 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2010to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients who have been enrolled into the PEP programme will be included in the evaluation on process of care; whereas all enrolled subjects who have been recruited for more than 12 months in the programme will be included in the evaluation on the clinical outcomes of care. An equal number of a random sample of eligible subjects who refused to take part in the PEP will be used as controls for the evaluation on the clinical outcomes of care.
Who may be able to join
- Eligible patients who are ambulatory, have stable mental and emotional conditions, and follow up at general outpatients clinics (GOPC) and family medicine specialist clinics (FMSC) regularly will be recruited for the PEP programme.
Who cannot join
- Patients will be excluded if they have severe heart failure, end stage renal failure (ESRF) or advanced eye diseases, are unable to understand or communicate in Chinese language, or refuse to give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes mellitus (DM) and hypertension (HT) are major causes 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 patient empowerment programme (PEP) to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Family Medicine Unit (FMU) 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 PEP programme is achieved. Each PEP participating clinic and non-government organization (NGO) will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the PEP for more than one year will be included in the evaluation on the process and 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 planned process of care and achieved the target HbA1c and blood pressure levels.
Read more
Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The changes in clinical, service, and patient reported outcomes at 6 and 12 months will assessed by paired sample t-test. The audit cycle will be repeated annually over a period of 5 years.
Results: The QOC of the PEP 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 PEP programme can enhance QOC for patients with diabetes mellitus (DM) or hypertension (HT). The information will be used to guide service planning and policy decision making.
- Conditions
- Diabetes Mellitus, Hypertension
- Keywords
- Diabetes mellitus (DM), hypertension (HT), Hong Kong
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes mellitus (DM) and hypertension (HT) | Diabetes mellitus (DM) and/or hypertension (HT) patients in Hong Kong |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of clinics/NGO that have satisfied each of the set 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.
Measured: 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.
Measured: Five years
The proportion of DM 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.
Measured: Five years
The proportion of HT/ DM patients who have achieved the target blood pressure.
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.
Measured: Five years
Secondary outcomes (3)
Clinical outcomes including LDL, BMI, and cardiovascular complications.
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 5 years.
Measured: Five years
Patient reported outcomes (PRO) measured by the change in SF-12v2 scores, the Patient Enablement Index (PEI) and Global Rating of Change Score (GRS) at 6 months, and change in patient's knowledge on disease at 12 months.
Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.
Measured: Five years
GOPC consultation, SOPC, 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.
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startSep 2010
- Primary completionSep 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,496 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Professor Cindy L.K. Lam, The University of Hong Kong
- Investigators
- Cindy L.K. Lam, MD, Study chair, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong KongWilliam C.W. Wong, MD, Principal investigator, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935349
- Sponsor's protocol ID
- HKCTR-1187
- Acronym
- QoC PEP
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2013
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong CK, Wong WC, Lam CL, Wan YF, Wong WH, Chung KL, Dai D, Tsui EL, Fong DY. Effects of Patient Empowerment Programme (PEP) on clinical outcomes and health service utilization in type 2 diabetes mellitus in primary care: an observational matched cohort study. PLoS One. 2014 May 1;9(5):e95328. doi: 10.1371/journal.pone.0095328. eCollection 2014.
PubMed 24788804Wong CK, Wong WC, Wan YF, Chan AK, Chung KL, Chan FW, Lam CL. Patient Empowerment Programme in primary care reduced all-cause mortality and cardiovascular diseases in patients with type 2 diabetes mellitus: a population-based propensity-matched cohort study. Diabetes Obes Metab. 2015 Feb;17(2):128-35. doi: 10.1111/dom.12397. Epub 2014 Oct 20.
PubMed 25251664Wong CK, Wong WC, Wan YF, Chan AK, Chan FW, Lam CL. Patient Empowerment Programme (PEP) and Risk of Microvascular Diseases Among Patients With Type 2 Diabetes in Primary Care: A Population-Based Propensity-Matched Cohort Study. Diabetes Care. 2015 Aug;38(8):e116-7. doi: 10.2337/dc14-2213. No abstract available.
PubMed 26207061Wong CK, Wong WC, Wan EY, Wong WH, Chan FW, Lam CL. Increased number of structured diabetes education attendance was not associated with the improvement in patient-reported health-related quality of life: results from Patient Empowerment Programme (PEP). Health Qual Life Outcomes. 2015 Aug 12;13:126. doi: 10.1186/s12955-015-0324-3.
PubMed 26264130Wong CK, Wong WC, Wan EY, Chan AK, Chan FW, Lam CL. Macrovascular and microvascular disease in obese patients with type 2 diabetes attending structured diabetes education program: a population-based propensity-matched cohort analysis of Patient Empowerment Programme (PEP). Endocrine. 2016 Aug;53(2):412-22. doi: 10.1007/s12020-015-0843-z. Epub 2016 Jan 19.
PubMed 26785847Wong CK, Wong WC, Wan YF, Chan AK, Chan FW, Lam CL. Effect of a structured diabetes education programme in primary care on hospitalizations and emergency department visits among people with Type 2 diabetes mellitus: results from the Patient Empowerment Programme. Diabet Med. 2016 Oct;33(10):1427-36. doi: 10.1111/dme.12969. Epub 2015 Oct 27.
PubMed 26433212Wong CK, Lam CL, Wan EY, Chan AK, Pak CH, Chan FW, Wong WC. Evaluation of patient-reported outcomes data in structured diabetes education intervention: 2-year follow-up data of patient empowerment programme. Endocrine. 2016 Nov;54(2):422-432. doi: 10.1007/s12020-016-1015-5. Epub 2016 Sep 13.
PubMed 27623970
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Quality of Care - Patient Empowerment Programme, HA
- ClinicalTrials.gov ID
- NCT01935349
- Acronym / sponsor ID
- QoC PEP / HKCTR-1187
- Conditions
- Diabetes Mellitus, Hypertension
- Keywords
- Diabetes mellitus (DM), hypertension (HT), Hong Kong
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,496 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- Sep 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes mellitus (DM) and hypertension (HT) are major causes 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 patient empowerment programme (PEP) to improve the quality of care (QOC) for DM and HT patients. The evaluation on the QOC is an essential part of the programme in order to inform future policy. The Family Medicine Unit (FMU) 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 PEP programme is achieved. Each PEP participating clinic and non-government organization (NGO) will be invited to complete a structured evaluation questionnaire. The data of all patients who have enrolled into the PEP for more than one year will be included in the evaluation on the process and 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 planned process of care and achieved the target HbA1c and blood pressure levels.
Data Analysis: Descriptive statistics on proportions meeting the QOC criteria will be calculated. The changes in clinical, service, and patient reported outcomes at 6 and 12 months will assessed by paired sample t-test. The audit cycle will be repeated annually over a period of 5 years.
Results: The QOC of the PEP 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 PEP programme can enhance QOC for patients with diabetes mellitus (DM) or hypertension (HT). The information will be used to guide service planning and policy decision making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus (DM) and hypertension (HT) | – | –Diabetes mellitus (DM) and/or hypertension (HT) patients in Hong Kong |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have been enrolled into the PEP programme will be included in the evaluation on process of care; whereas all enrolled subjects who have been recruited for more than 12 months in the programme will be included in the evaluation on the clinical outcomes of care. An equal number of a random sample of eligible subjects who refused to take part in the PEP will be used as controls for the evaluation on the clinical outcomes of care.
Key inclusion criteria (1 listed)
- Eligible patients who are ambulatory, have stable mental and emotional conditions, and follow up at general outpatients clinics (GOPC) and family medicine specialist clinics (FMSC) regularly will be recruited for the PEP programme.
Key exclusion criteria (1 listed)
- Patients will be excluded if they have severe heart failure, end stage renal failure (ESRF) or advanced eye diseases, are unable to understand or communicate in Chinese language, or refuse to give consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of clinics/NGO that have satisfied each of the set structure criteria.
Time frame: Five years
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.
The proportion of patients who have complied with the criterion process of care.
Time frame: Five years
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.
The proportion of DM patients who have achieved a HbA1c level <7%.
Time frame: Five years
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.
The proportion of HT/ DM patients who have achieved the target blood pressure.
Time frame: Five years
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.
3 secondary outcomes
Clinical outcomes including LDL, BMI, and cardiovascular complications.
Time frame: Five years
Patient reported outcomes (PRO) measured by the change in SF-12v2 scores, the Patient Enablement Index (PEI) and Global Rating of Change Score (GRS) at 6 months, and change in patient's knowledge on disease at 12 months.
Time frame: Five years
GOPC consultation, SOPC, A&E and hospital attendance rates in the past 12 months.
Time frame: Five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Results publication: PubMed 24788804Wong CK, Wong WC, Lam CL, Wan YF, Wong WH, Chung KL, Dai D, Tsui EL, Fong DY. Effects of Patient Empowerment Programme (PEP) on clinical outcomes and health service utilization in type 2 diabetes mellitus in primary care: an observational matched cohort study. PLoS One. 2014 May 1;9(5):e95328. doi: 10.1371/journal.pone.0095328. eCollection 2014.
- Results publication: PubMed 25251664Wong CK, Wong WC, Wan YF, Chan AK, Chung KL, Chan FW, Lam CL. Patient Empowerment Programme in primary care reduced all-cause mortality and cardiovascular diseases in patients with type 2 diabetes mellitus: a population-based propensity-matched cohort study. Diabetes Obes Metab. 2015 Feb;17(2):128-35. doi: 10.1111/dom.12397. Epub 2014 Oct 20.
- Results publication: PubMed 26207061Wong CK, Wong WC, Wan YF, Chan AK, Chan FW, Lam CL. Patient Empowerment Programme (PEP) and Risk of Microvascular Diseases Among Patients With Type 2 Diabetes in Primary Care: A Population-Based Propensity-Matched Cohort Study. Diabetes Care. 2015 Aug;38(8):e116-7. doi: 10.2337/dc14-2213. No abstract available.
- Results publication: PubMed 26264130Wong CK, Wong WC, Wan EY, Wong WH, Chan FW, Lam CL. Increased number of structured diabetes education attendance was not associated with the improvement in patient-reported health-related quality of life: results from Patient Empowerment Programme (PEP). Health Qual Life Outcomes. 2015 Aug 12;13:126. doi: 10.1186/s12955-015-0324-3.
- Results publication: PubMed 26785847Wong CK, Wong WC, Wan EY, Chan AK, Chan FW, Lam CL. Macrovascular and microvascular disease in obese patients with type 2 diabetes attending structured diabetes education program: a population-based propensity-matched cohort analysis of Patient Empowerment Programme (PEP). Endocrine. 2016 Aug;53(2):412-22. doi: 10.1007/s12020-015-0843-z. Epub 2016 Jan 19.
- Results publication: PubMed 26433212Wong CK, Wong WC, Wan YF, Chan AK, Chan FW, Lam CL. Effect of a structured diabetes education programme in primary care on hospitalizations and emergency department visits among people with Type 2 diabetes mellitus: results from the Patient Empowerment Programme. Diabet Med. 2016 Oct;33(10):1427-36. doi: 10.1111/dme.12969. Epub 2015 Oct 27.
- Results publication: PubMed 27623970Wong CK, Lam CL, Wan EY, Chan AK, Pak CH, Chan FW, Wong WC. Evaluation of patient-reported outcomes data in structured diabetes education intervention: 2-year follow-up data of patient empowerment programme. Endocrine. 2016 Nov;54(2):422-432. doi: 10.1007/s12020-016-1015-5. Epub 2016 Sep 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L.K. Lam, MD study chair
Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
William C.W. Wong, MD principal investigator
Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Hypertension, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of clinics/NGO that have satisfied each of the set structure criteria. (time frame: Five years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01935349, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2017.