NCT02762695

Brief 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. Additionally, this intervention would provide a better quality of care and a more efficient health provision.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
616

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started May 2016

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

May 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

2.1 years

First QC Date

May 3, 2016

Last Update Submit

September 26, 2017

Conditions

Keywords

HypertensionDiabetes Mellitus, Type 2Case Management

Outcome Measures

Primary Outcomes (2)

  • Glycated Hemoglobin

    One year

  • Systolic and Diastolic Blood Pressure

    One year

Secondary Outcomes (3)

  • Quality of Care

    one year

  • Patient satisfaction

    one year

  • Medication adherence

    one year

Study Arms (2)

Case Management

EXPERIMENTAL
Other: Case Management

Control

ACTIVE COMPARATOR

Usual Care at Primary Health Care

Other: Usual Care

Interventions

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.

Case Management

Usual Care at Primary Health Care Center

Control

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults diagnosed with Hypertension and/ or Type 2 Diabetes

You may not qualify if:

  • Severe mental illness and / or deterioration of cognitive abilities.
  • Severe hearing loss.
  • Diagnosed with cancer
  • Stage 4 or 5 of chronic kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CESFAM La Faena

Peñalolén, RM, Chile

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2

Interventions

Case Management

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Fernando C Poblete, Master

    Pontificia Universidad Catolica de Chile

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MPH

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 5, 2016

Study Start

May 4, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

September 28, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations