Patients at Risk of Hospital AdmissionNCT03628469
Proactive Health Support
A study testing Proactive Health Support in people with Patients at Risk of Hospital Admission, run by Frederiksberg University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients at Risk of Hospital Admission
- What is being tested?
- Proactive Health Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,454 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Apr 2018to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- Hearing impairment
- Not speaking Danish
- Cognitive impairment
- Substance abuse, that impairs adherence
- No telephone
- Receiving similar trial intervention
- Other (including intervention not suitable)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patients at Risk of Hospital Admission
- Being tested
- Proactive Health Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive Health SupportBehavioural
Active listening, coaching and counselling
| Study group | Role | What they receive |
|---|---|---|
| Proactive Health Support | Experimental | 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. Receives: Behavioral: Proactive Health Support |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admissions
Measured: 6 months
Quality of life
Questionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal)
Measured: 6 months
Secondary outcomes (9)
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)
Measured: 3, 6 and 12 months
Outpatient consultations
Measured: 3, 6 and 12 months
Use of primary healthcare
Measured: 3, 6 and 12 months
Use of prescription medication
Measured: 3, 6 and 12 months
Survival
Measured: 1 year
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)
Measured: 3, 6 and 12 months
Incremental cost effectiveness ratio by comparison of costs with quality adjusted life years
Measured: 3, 6 and 12 months
Regional differences in resource use and costs
Measured: 3, 6 and 12 months
Resource use in primary care and rehabilitation
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start9 Apr 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients at Risk of Hospital AdmissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with 1:1 randomization stratified for risk of hospital admission and region
- Masking
- None (open label)
- Enrolment
- 5,454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulla Toft, Frederiksberg University Hospital
- Investigators
- Ulla Toft, PhD, Principal investigator, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628469
- Sponsor's protocol ID
- SJ-677
- Status last verified
- Feb 2020
- First submitted
- 1 Aug 2018
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fredens M, Terkildsen MD, Gronkjaer M, Toft U, Hawkins J, Nielsen CP. Balancing standardisation and flexibility in National complex intervention scale-up: a qualitative study of leadership experiences and management in the implementation of Proactive Health Support in Denmark. BMC Health Serv Res. 2026 Jun 30. doi: 10.1186/s12913-026-15030-y. Online ahead of print.
PubMed 42380860Benthien 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.
PubMed 32320846
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Health Support - a Randomized Controlled Trial of Telephone-based Self-management Support
- ClinicalTrials.gov ID
- NCT03628469
- Acronym / sponsor ID
- SJ-677
- Conditions
- Patients at Risk of Hospital Admission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,454 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with 1:1 randomization stratified for risk of hospital admission and region
| Arm | Type | Receives |
|---|---|---|
| Proactive Health Support | Experimental | Behavioral: Proactive Health SupportThe 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. |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive Health SupportActive listening, coaching and counselling | Behavioural | Proactive Health Support |
Primary outcome
Hospital admissions
Time frame: 6 months
Quality of life
Time frame: 6 months
Questionnaire SF 36 - Mental Health Composite Score (Norm-based T-score of 45-55 is considered normal)
9 secondary outcomes
Patient education
Time frame: 3, 6 and 12 months
Outpatient consultations
Time frame: 3, 6 and 12 months
Use of primary healthcare
Time frame: 3, 6 and 12 months
Use of prescription medication
Time frame: 3, 6 and 12 months
Survival
Time frame: 1 year
Quality of life
Time frame: 3, 6 and 12 months
Incremental cost effectiveness ratio by comparison of costs with quality adjusted life years
Time frame: 3, 6 and 12 months
Regional differences in resource use and costs
Time frame: 3, 6 and 12 months
Resource use in primary care and rehabilitation
Time frame: 3, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Derived from this study: PubMed 42380860Fredens M, Terkildsen MD, Gronkjaer M, Toft U, Hawkins J, Nielsen CP. Balancing standardisation and flexibility in National complex intervention scale-up: a qualitative study of leadership experiences and management in the implementation of Proactive Health Support in Denmark. BMC Health Serv Res. 2026 Jun 30. doi: 10.1186/s12913-026-15030-y. Online ahead of print.
- Derived from this study: PubMed 32320846Benthien 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulla Toft, PhD principal investigator
Frederiksberg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Health Support in people with Patients at Risk of Hospital Admission, run by Frederiksberg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital admissions (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03628469, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.