Proactive Health Support

Not Applicable

Completed

• Conditions: Patients at Risk of Hospital Admission
• Interventions: Behavioral: Proactive Health Support

• Registration Number: NCT03628469
• Lead Sponsor: Frederiksberg University Hospital

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.

Study Timeline

• Study Start: 2018-04-09
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-14
• Status Verified: 2020-02
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5454

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proactive Health Support	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Survival	1 year
Patient education	3, 6 and 12 months	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)
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	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)

Trial Locations

Locations (1)

Center for Clinical Research and Prevention; 🇩🇰 Frederiksberg, Denmark