Proactive Health Support - a Randomized Controlled Trial of Telephone-based Self-management Support

Frederiksberg University Hospital1 site in 1 country5,454 target enrollmentApril 9, 2018

ConditionsPatients at Risk of Hospital Admission

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients at Risk of Hospital Admission
Sponsor: Frederiksberg University Hospital
Enrollment: 5454
Locations: 1
Primary Endpoint: Hospital admissions
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Proactive Health Support is a randomized controlled trial of telephone-based self-management support. The primary aim of the intervention is to reduce hospital admissions and improve quality of life in patients with a high risk of hospital admission.

Detailed Description

Participants are identified through an algorithm, that assigns each patient with a risk score of 0-100%. Patients with the highest risk in each of the five regions of Denmark are invited to participate.

Registry

clinicaltrials.gov

Start Date

April 9, 2018

End Date

February 1, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Frederiksberg University Hospital

Responsible Party

Principal Investigator

Ulla Toft

Senior Researcher, Principal Investigator

Frederiksberg University Hospital

Eligibility Criteria

Inclusion Criteria

•Persons with a hospital contact within the last year caused by ≥ 1 of the following diagnoses: heart diseases (DI110, DI130, DI132, DI50), connective tissue diseases (DD86, DM05, DM06, DM08, DM09, DM30, DM31, DM32, DM33, DM34, DM35, DM36), pulmonary diseases (DJ40, DJ41, DJ42, DJ43, DJ44, DJ45, DJ46, DJ47, DJ60, DJ61, , DJ62, DJ63, DJ64, DJ65, DJ66, DJ67, DJ684, DJ701, DJ703, DJ841, DJ842, DJ843, DJ848, DJ849, DJ920, DJ961, DJ982, DJ983) or diabetes (DE10, DE11, DE14) Or
•Persons ≥ 18 years and ≥ three unplanned hospital admissions in the last six months Or
•Persons ≥ 65 years with a preventable hospital admission (predefined diagnoses: dehydration, constipation, lower respiratory tract infections, urinary tract infections, gastroenteritis, fractures, nutrition deficiency anemia, social causes and pressure ulcers) or a readmission (within 30 days)

Exclusion Criteria

•Selected psychiatric diagnoses: substance abuse disorder (DF1), schizophrenia (DF2) or dementia (DF00, DF01, DF02, DF03, DF051)
•Metastatic cancer (DC77, DC78, DC79, DC80)
•Assisted living Facility
•Documented terminal illness or life expectancy \< one year
•Assessment of dementia
•Major surgery planned within 6 months
•Hearing impairment
•Not speaking Danish
•Cognitive impairment
•Substance abuse, that impairs adherence

Outcomes

Primary Outcomes

Hospital admissions

Time Frame: 6 months

Quality of life

Time Frame: 6 months

Questionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal)

Secondary Outcomes

Survival(1 year)
Patient education(3, 6 and 12 months)
Incremental cost effectiveness ratio by comparison of costs with quality adjusted life years(3, 6 and 12 months)
Regional differences in resource use and costs(3, 6 and 12 months)
Outpatient consultations(3, 6 and 12 months)
Use of primary healthcare(3, 6 and 12 months)
Use of prescription medication(3, 6 and 12 months)
Resource use in primary care and rehabilitation(3, 6 and 12 months)
Quality of life(3, 6 and 12 months)