Proactive Health Support

Patients at Risk of Hospital Admission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628469
• Other study ID #: SJ-677
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5454
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Patients at Risk of Hospital Admission

Intervention

Behavioral:
• Proactive Health Support
Active listening, coaching and counselling

Locations

Country	Name	City	State
Denmark	Center for Clinical Research and Prevention	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital admissions		6 months
Primary	Quality of life	Questionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal)	6 months
Secondary	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
Secondary	Outpatient consultations		3, 6 and 12 months
Secondary	Use of primary healthcare		3, 6 and 12 months
Secondary	Use of prescription medication		3, 6 and 12 months
Secondary	Survival		1 year
Secondary	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
Secondary	Incremental cost effectiveness ratio by comparison of costs with quality adjusted life years		3, 6 and 12 months
Secondary	Regional differences in resource use and costs		3, 6 and 12 months
Secondary	Resource use in primary care and rehabilitation		3, 6 and 12 months