Skip to main content
OpenTrials
Completed

NCT Number: NCT03628469

Proactive Health 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patients at Risk of Hospital Admission

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Research and Prevention

Frederiksberg, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Proactive Health Support

Behavioral

Active listening, coaching and counselling

Primary outcomes

  1. Hospital admissions

    Time frame: 6 months

  2. Quality of life

    Time frame: 6 months

    Questionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal)

Secondary outcomes

  1. Patient education

    Time frame: 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)

  2. Outpatient consultations

    Time frame: 3, 6 and 12 months

  3. Use of primary healthcare

    Time frame: 3, 6 and 12 months

  4. Use of prescription medication

    Time frame: 3, 6 and 12 months

  5. Survival

    Time frame: 1 year

  6. Quality of life

    Time frame: 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)

  7. Incremental cost effectiveness ratio by comparison of costs with quality adjusted life years

    Time frame: 3, 6 and 12 months

  8. Regional differences in resource use and costs

    Time frame: 3, 6 and 12 months

  9. Resource use in primary care and rehabilitation

    Time frame: 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Frederiksberg University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2018
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.