NCT02583555

Brief Summary

The purpose of this study is to identify persons with high risk of frequent hospital admissions and by counselling by one in depth interview followed by frequent telephone contacts improve their quality of life and reduce their healthcare utilization.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

October 20, 2015

Last Update Submit

October 21, 2015

Conditions

Quality of Life

Keywords

Quality of LifeHealth Care Utilization

Outcome Measures

Primary Outcomes (2)

  • Quality of Life reported by the participants with use of Short Form 36

    Questionaire Short Form-36 Every 3 months for one year

  • Health Care Utilization - Admissions to and days in hospital

    The use of different health care systems will be recorded

    One year

Study Arms (2)

Active patient support

ACTIVE COMPARATOR

Interview followed by frequent telephone support Questionnaire every 3 months

Behavioral: Interview followed by frequent telephone support

Controls

NO INTERVENTION

Questionnaire every 3 months

Interventions

Interview followed by frequent telephone supportBEHAVIORAL

Interview followed by telephone support

Active patient support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient \> 18 years
  • Recent history of contact with hospital
  • Anticipated sustained high visit frequency

You may not qualify if:

  • Dementia (ICD10: F00-F03 or F051)
  • Psychoses (ICD10: F20-F29)
  • Drug abuse (ICD10: F10-F19)
  • Metastases (ICD10: C77-C80)
  • Hearing impairment or language difficulties
  • Life expectancy \< 1 year No telephone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Research

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Knud Rasmussen, MD DMSci

    Research Consultant

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Knud Rasmussen, MD DMSci

CONTACT

+45 60168891kra@regionsjaelland.dk

Ellen B Zacho, Chief Consul

CONTACT

+ 45 24835717ellenz@regionsjaelland.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Consultant, MD, DMSci

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 22, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

May 1, 2017

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

DK(1)