HypertensionNCT02762695
Effectiveness of a Case Management Model for Patients With Hypertension and Type II Diabetes in Chile
A study testing Case Management in people with Hypertension and Diabetes Mellitus, Type 2, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The purpose of this study is to evaluate whether a new model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk, is more effective than usual care at Primary Health care in Chile. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Type 2
- What is being tested?
- Case Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 1 siteChile
- Study dates
- 4 May 2016to Jun 2018
- Phase
- Interventional
- 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 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults diagnosed with Hypertension and/ or Type 2 Diabetes
Who cannot join
- Severe mental illness and / or deterioration of cognitive abilities.
- Severe hearing loss.
- Diagnosed with cancer
- Stage 4 or 5 of chronic kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Model of Care for People With Hypertension and Type II Diabetes Based on Case Management and Risk Adjustment
The purpose of this study is to evaluate whether a new model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk, is more effective than usual care at Primary Health care in Chile. Additionally, this intervention would provide a better quality of care and a more efficient health provision.
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Being tested
- Case Management, Usual Care
- Keywords
- Hypertension, Diabetes Mellitus, Type 2, Case Management
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case ManagementOther
A model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk.
The core elements of this strategy are: a. processes to identify specific population and their risk; b. evidence-based practice guidelines according to risk (higher risk, more interventions and monitoring by a nurse, lower risk, higher emphasis on self-care); c. Practice models based on collaboration between health team members leaded by a nurse; d. self-management education for patients; e. monitoring patients face to face or by telephone to ensure to follow the care program (blood test, medical consultation, for example); e. measurement of process and outcomes.
Usual CareOther
Usual Care at Primary Health Care Center
| Study group | Role | What they receive |
|---|---|---|
| Case Management | Experimental | Not described Receives: Other: Case Management |
| Control | Active comparator | Usual Care at Primary Health Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin
Measured: One year
Systolic and Diastolic Blood Pressure
Measured: One year
Secondary outcomes (3)
Quality of Care
Measured by Clinical records audits
Measured: one year
Patient satisfaction
Measured by a questionnaire
Measured: one year
Medication adherence
Measured by Morisky- Green questionnaire
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start4 May 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Responsible party
- Principal investigator, Fernando Poblete Arrué, Pontificia Universidad Catolica de Chile
- Investigators
- Fernando C Poblete, Master, Study chair, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762695
- Sponsor's protocol ID
- 15-277
- Other IDs
- ID15I10277
- Status last verified
- Sep 2017
- First submitted
- 3 May 2016
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Model of Care for People With Hypertension and Type II Diabetes Based on Case Management and Risk Adjustment
- ClinicalTrials.gov ID
- NCT02762695
- Acronym / sponsor ID
- 15-277
- Conditions
- Hypertension, Diabetes Mellitus, Type 2
- Keywords
- Hypertension, Diabetes Mellitus, Type 2, Case Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 616 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- 4 May 2016 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 5 May 2016 (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.
The purpose of this study is to evaluate whether a new model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk, is more effective than usual care at Primary Health care in Chile. Additionally, this intervention would provide a better quality of care and a more efficient health provision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Management | Experimental | Other: Case Management |
| Control | Active comparator | Other: Usual CareUsual Care at Primary Health Care |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults diagnosed with Hypertension and/ or Type 2 Diabetes
Key exclusion criteria (4 listed)
- Severe mental illness and / or deterioration of cognitive abilities.
- Severe hearing loss.
- Diagnosed with cancer
- Stage 4 or 5 of chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case ManagementA model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk. The core elements of this strategy are: a. processes to identify specific population and their risk; b. evidence-based practice guidelines according to risk (higher risk, more interventions and monitoring by a nurse, lower risk, higher emphasis on self-care); c. Practice models based on collaboration between health team members leaded by a nurse; d. self-management education for patients; e. monitoring patients face to face or by telephone to ensure to follow the care program (blood test, medical consultation, for example); e. measurement of process and outcomes. | Other | Case Management |
| Usual CareUsual Care at Primary Health Care Center | Other | Control |
Primary outcome
Glycated Hemoglobin
Time frame: One year
Systolic and Diastolic Blood Pressure
Time frame: One year
3 secondary outcomes
Quality of Care
Time frame: one year
Patient satisfaction
Time frame: one year
Medication adherence
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Fernando C Poblete, Master study chair
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Management in people with Hypertension and Diabetes Mellitus, Type 2, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 4 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: status not confirmed, as of the sponsor's last update on 28 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 Chile. 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?
Results are not available in the source record.
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?
Glycated Hemoglobin (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2017.