HypertensionNCT02219958
Evaluation of Quality of Care - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)
An observational study of Hypertension, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Hypertension (HT) 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 2,496 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2012to 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
- No healthy volunteers
- Adult, Older adult
Study population: All HT patients aged <80, without prior history of diabetes and existing cardiovascular diseases, with suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average diastolic blood pressure (DBP) ≥ 90mmHg) who were enrolled into RAMP-HT.
Who may be able to join
- HT
- aged <80
- Suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average diastolic blood pressure (DBP) ≥ 90mmHg)
Who cannot join
- Patients will be excluded if they are unable to understand or communicate in Chinese language, or refuse to give consent.
- Patients will be excluded if they had prior history of diabetes and existing cardiovascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
Hypertension (HT) 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 HT 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.
Read more
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 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 HT patients. The information will be used to guide service planning and policy decision making.
- Conditions
- Hypertension
- Keywords
- Hypertension
- Medical subject headings
- 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 |
|---|---|---|
| RAMP-HT and Non-RAMP-HT | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of clinics that have satisfied each of the structure criteria
Final analysis will evaluate the period from August, 2012 to December, 2014.
Measured: Three years
The proportion of patients who have complied with the criterion process of care.
Final analysis will evaluate the period from August, 2012 to December, 2014.
Measured: Three years
The proportion of patients who have achieved a BP level <140/90mmHg.
Final analysis will evaluate the period from August, 2012 to December, 2014.
Measured: Three years
Secondary outcomes (6)
LDL
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.
Measured: Three years
BMI (Body Mass Index)
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.
Measured: Three years
Occurrence of First Cardiovascular Complication
Baseline and 12 months for each subject; the audit cycle will be repeated annually over a period of 3 years.
Measured: Three years
The change in SF-12v2 scores
Baseline and 6-month/12-month/24-month/36-month after the first administration of questionnaire.
Measured: Three years
PEI (Patient Enablement Index)
6-month/12-month/24-month/36-month after the first administration of questionnaire.
Measured: Three years
GRS (Global Rating of Change Scale) scores
6-month/12-month/24-month/36-month after the first administration of questionnaire.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startSep 2012
- 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 (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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 KongEsther Y.T. Yu, MBBS, Principal investigator, Department of Family Medicine and Primary Care, Faculty of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219958
- Sponsor's protocol ID
- HKCTR-1685
- Status last verified
- Sep 2017
- First submitted
- 14 Aug 2014
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu EY, Wan EY, Chan KH, Wong CK, Kwok RL, Fong DY, Lam CL. Evaluation of the quality of care of a multi-disciplinary Risk Factor Assessment and Management Programme for Hypertension (RAMP-HT). BMC Fam Pract. 2015 Jun 19;16:71. doi: 10.1186/s12875-015-0291-0.
PubMed 26088560Yu EYT, Wan EYF, Mak IL, Chao DVK, Ko WWK, Leung M, Li YC, Liang J, Luk W, Wong MMY, Ha TKH, Chan AKC, Fong DYT, Lam CLK. Assessment of Hypertension Complications and Health Service Use 5 Years After Implementation of a Multicomponent Intervention. JAMA Netw Open. 2023 May 1;6(5):e2315064. doi: 10.1001/jamanetworkopen.2023.15064.
PubMed 37223900
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 - Multi-disciplinary Risk Assessment and Management Programme for Patients With Hypertension, HA (QoC RAMP-HT)
- ClinicalTrials.gov ID
- NCT02219958
- Acronym / sponsor ID
- HKCTR-1685
- Conditions
- Hypertension
- Keywords
- Hypertension
- 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 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 19 Aug 2014 (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.
Hypertension (HT) 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 HT 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 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 HT patients. 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 |
|---|---|---|
| RAMP-HT and Non-RAMP-HT | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All HT patients aged <80, without prior history of diabetes and existing cardiovascular diseases, with suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average diastolic blood pressure (DBP) ≥ 90mmHg) who were enrolled into RAMP-HT.
Key inclusion criteria (3 listed)
- HT
- aged <80
- Suboptimal BP control (average systolic blood pressure (SBP) ≥ 140mmHg or average diastolic blood pressure (DBP) ≥ 90mmHg)
Key exclusion criteria (2 listed)
- Patients will be excluded if they are unable to understand or communicate in Chinese language, or refuse to give consent.
- Patients will be excluded if they had prior history of diabetes and existing cardiovascular diseases
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 that have satisfied each of the structure criteria
Time frame: Three years
Final analysis will evaluate the period from August, 2012 to December, 2014.
The proportion of patients who have complied with the criterion process of care.
Time frame: Three years
Final analysis will evaluate the period from August, 2012 to December, 2014.
The proportion of patients who have achieved a BP level <140/90mmHg.
Time frame: Three years
Final analysis will evaluate the period from August, 2012 to December, 2014.
6 secondary outcomes
LDL
Time frame: Three years
BMI (Body Mass Index)
Time frame: Three years
Occurrence of First Cardiovascular Complication
Time frame: Three years
The change in SF-12v2 scores
Time frame: Three years
PEI (Patient Enablement Index)
Time frame: Three years
GRS (Global Rating of Change Scale) scores
Time frame: Three 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 26088560Yu EY, Wan EY, Chan KH, Wong CK, Kwok RL, Fong DY, Lam CL. Evaluation of the quality of care of a multi-disciplinary Risk Factor Assessment and Management Programme for Hypertension (RAMP-HT). BMC Fam Pract. 2015 Jun 19;16:71. doi: 10.1186/s12875-015-0291-0.
- Derived from this study: PubMed 37223900Yu EYT, Wan EYF, Mak IL, Chao DVK, Ko WWK, Leung M, Li YC, Liang J, Luk W, Wong MMY, Ha TKH, Chan AKC, Fong DYT, Lam CLK. Assessment of Hypertension Complications and Health Service Use 5 Years After Implementation of a Multicomponent Intervention. JAMA Netw Open. 2023 May 1;6(5):e2315064. doi: 10.1001/jamanetworkopen.2023.15064.
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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
Esther Y.T. Yu, MBBS 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 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 3 inclusion and 2 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 that have satisfied each of the structure criteria (time frame: Three years). The study lists 3 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 NCT02219958, which also lists 2 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.