Proactive Health Support

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

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.

Study Overview

• Status: Completed
• Conditions: Patients at Risk of Hospital Admission
• Intervention / Treatment: Behavioral: Proactive Health Support

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.

• Study Type: Interventional
• Enrollment (Actual): 5454
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Denmark
    • Center for Clinical Research and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: 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.	Behavioral: Proactive Health Support; Active listening, coaching and counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital admissions		6 months
Quality of life	Questionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival		1 year
Patient education	Questionnaire Hei-Q - all 8 subscales (health-directed activities, positive and active engagement in life, emotional distress, self-monitoring and insight, constructive attitudes and approaches, skill and technique acquisition, social integration and support, health service navigation, range 1-4)	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
Quality of life	Questionnaire SF36: All eight subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health and health transition, range 0-100. Furthermore, norm-based T-scores are reported, 45-55 is considered normal) and two composite scores (mental and physical health, norm-based T-score of 45-55 is considered normal)	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
Resource use in primary care and rehabilitation		3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Frederiksberg University Hospital
• Investigators: Principal Investigator: Ulla Toft, PhD, Frederiksberg University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SJ-677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No