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Proactive Health Support

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03628469
Enrollment
5454
Registered
2018-08-14
Start date
2018-04-09
Completion date
2020-02-01
Last updated
2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients at Risk of Hospital Admission

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.

Interventions

BEHAVIORALProactive Health Support

Active listening, coaching and counselling

Sponsors

Frederiksberg University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Hospital admissions6 months
Quality of life6 monthsQuestionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal)

Secondary

MeasureTime frameDescription
Use of primary healthcare3, 6 and 12 months
Use of prescription medication3, 6 and 12 months
Survival1 year
Patient education3, 6 and 12 monthsQuestionnaire 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 years3, 6 and 12 months
Regional differences in resource use and costs3, 6 and 12 months
Resource use in primary care and rehabilitation3, 6 and 12 months
Quality of life3, 6 and 12 monthsQuestionnaire 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)
Outpatient consultations3, 6 and 12 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026