Please select the eligibility criteria that correspond to the clinical trial below.
Title: Empowering Primary Care Providers and Patients to Improve Chronic Disease Outcomes: The EMPOWER Participatory Action Research (EMPOWER - PAR)
Brief Summary: BACKGROUND

Chronic disease management (CDM) presents enormous challenges to the primary care workforce due to the rising epidemic of cardiovascular risk factors. The Chronic Care Model (CCM) was proven effective in improving chronic disease outcomes in developed countries. Evidence that this model works in developing countries is still scarce. Therefore, the aim of this study is to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted CDM strategies based on the CCM) in managing type 2 diabetes mellitus (T2DM) and hypertension (HPT), using readily available resources in the Malaysian public primary care setting.

METHODS

This is a pragmatic cluster randomised controlled trial - participatory action research which is currently being conducted in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics are randomly selected to provide the EMPOWER-PAR intervention for 1 year, while the other 5 clinics continued with usual care. Each clinic recruits consecutive T2DM and HPT patients who fulfil the inclusion and exclusion criteria over a 2-week period.

The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary CDM Team; and training the team to utilise the Global CV Risks Self-Management Booklet to support patient care and reinforcing them to utilise relevant clinical practice guidelines to aid management and prescribing.

For T2DM, primary outcome is the change in the proportion of patients achieving target HbA1c of \<6.5%. For HPT without T2DM, primary outcome is the change in the proportion of patients achieving target blood pressure of \<140/90 mmHg. Secondary outcomes include the proportion of patients achieving targets serum lipid profile, body mass index and waist circumference. Other outcome measures include medication adherence levels, process of care and prescribing patterns. Patients' assessment of their chronic disease care, providers' perception, attitude and perceived barriers in delivering the care and cost-effectiveness of the intervention are also evaluated.

CONCLUSION

Results from this study will provide objective evidence of the effectiveness and cost-effectiveness of a multifaceted intervention based on the CCM in resource constraint public primary care setting. It is hoped that the evidence will instigate the much needed primary care system change in Malaysia.


Options:
A: Inclusion Criteria:

* Men and women age 18 years or older,
* Ability to understand and read English,
* Be empanelled to one of the target PCMH sites, and
* Diagnosed with type 2 diabetes.

Exclusion Criteria:

* pregnant women,
* non-English speaking patients,
* receiving hospice care,
* active cancer and treatment with chemotherapy or radiation therapy,
* taking Coumadin,
* recipient of gastric bypass or similar procedure,
* diagnosis of uncontrolled hypothyroidism,
* known Cushing's syndrome,
* being treated with oral steroids,
* known liver disease,
* current diagnosis of cognitive impairments which would interfere with use of technology,
* congestive heart failure New York Heart Association class 3 or 4,
* inability to use a mobile device due to cognitive or physical impairments, and
* PAM® score = 4 during initial screening.
B: Inclusion criteria

Males and females aged ≥ 18 years who are diagnosed with:

1. T2DM or HPT or both
2. Seen at least once in the last one year at the primary care clinic for the above conditions

Exclusion criteria

1. Type 1 Diabetes Mellitus
2. Receiving renal dialysis
3. Presenting with severe HPT (Systolic BP \>180mmHg and/or Diastolic BP \>110 mmHg)
4. Diagnosed with conditions resulting in secondary hypertension
5. Diagnosed to have circulatory disorders needing referral to secondary care over the last 1 year e.g. unstable angina, heart attack, stroke, transient ischaemic attacks
6. Receiving shared care between primary and secondary care for complications of T2DM and/or HPT
7. Pregnancy
8. Enrolled in another study

All patients in the intervention arm are required to be seen at least twice by the CDM team of each clinic during the 1-year intervention period. Those who do not comply are considered as lost to follow-up. There is no limit to the number of clinic visits a patient is allowed to make in either arm during the course of the study.
C: Inclusion Criteria:

* Age 55 years or greater
* Being a current Medicare beneficiary (verified by the Centers for Medicare and Medicaid Services)
* Having diabetes mellitus as defined by a physician's diagnosis and being on treatment with diet, an oral hypoglycemic agent, or insulin
* Residence in a federally designated medically underserved area (either of two federal designations, Medically Underserved Area \[MUA\] or Health Manpower Shortage Area \[HPSA\]) in New York Sate
* Fluency in either English or Spanish

Exclusion Criteria:

* Moderate or severe cognitive, visual, or physical impairment
* The presence of severe co-morbid disease.
D: Inclusion Criteria:

* Type 2 diabetes diagnosed by a physician at least six months prior to study enrollment
* HbA1c of \> 7.5% but less than 11.0% within the most recent 3 months
* Access to internet and an e-mail address , or access to a smartphone with 3G services
* Not pregnant or history of heart diseases, serious illness, cancer diagnosis or any other conditions that can impede participation

Exclusion Criteria:

* Unable or unwilling to give informed consent or communicate with local study staff
* Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
* Hospitalization for depression in past six months
* Plans to relocate to an area or travel plans that do not permit full participation in the study
* Lack of support from primary health care provider or family members
* History of bariatric surgery, small bowel resection, or extensive bowel resection
* Currently pregnant or nursing
* Cancer: requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
* Cardiovascular disease (heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Answer: B