Proactive Health Support

NCT ID: NCT03628469

Last Updated: 2020-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5454 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-09

Study Completion Date

2020-02-01

Brief Summary

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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

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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.

Conditions

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Patients at Risk of Hospital Admission

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with 1:1 randomization stratified for risk of hospital admission and region
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Proactive Health Support

The purpose of the intervention is to enhance patients' self-management strategies and thereby enable patients to cope with illness at home and prevent the development of those conditions, that are sensitive to preventive efforts.The intervention includes active listening, coaching and counselling and elements from case management such as assessing the need for healthcare services. Emphasis is on supporting and empowering the patient to make the necessary contacts to healthcare professionals.

Group Type EXPERIMENTAL

Proactive Health Support

Intervention Type BEHAVIORAL

Active listening, coaching and counselling

Usual care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Proactive Health Support

Active listening, coaching and counselling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
* No telephone
* Receiving similar trial intervention
* Other (including intervention not suitable)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ulla Toft

Senior Researcher, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulla Toft, PhD

Role: PRINCIPAL_INVESTIGATOR

Frederiksberg University Hospital

Locations

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Center for Clinical Research and Prevention

Frederiksberg, , Denmark

Site Status

Countries

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Denmark

References

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Benthien KS, Rasmussen K, Nielsen CP, Hjarnaa L, Rasmussen MK, Kidholm K, Nielsen BK, Nissen NK, Fredens M, Winther S, Gronkjaer M, Toft U. Proactive health support (PaHS) - telephone-based self-management support for persons at risk of hospital admission: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2020 Jun;93:106004. doi: 10.1016/j.cct.2020.106004. Epub 2020 Apr 19.

Reference Type DERIVED
PMID: 32320846 (View on PubMed)

Other Identifiers

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SJ-677

Identifier Type: -

Identifier Source: org_study_id

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