NCT02457533

Brief Summary

To investigate the effects of patient counseling by telephone on Quality of Life and the use of Health care system.

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

Timeline
Completed

Started Apr 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

April 23, 2015

Last Update Submit

May 26, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of Life questionnaire SF-36 (Short-Form Health Survey)

    Participants will be followed an expected avarage of 6 months

Secondary Outcomes (1)

  • Analysis of patients use of Health Care system

    1 year

Study Arms (2)

Control

NO INTERVENTION

Only SF-36 and CAT

Active

ACTIVE COMPARATOR

Lifestyle behavioral. Health plan, telephone support

Behavioral: Lifestyle behavioral. Health plan, telephone support

Interventions

'Lifestyle behavioral. Health plan, telephone support'

Active

Eligibility Criteria

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

You may qualify if:

  • Patient living in The Zealand Region.
  • A COLD-related contact with hospital with-in 6 months.
  • Predicted to be in high risk of new hospital admission.

You may not qualify if:

  • Dementia.
  • Psychosis.
  • Drug-addiction.
  • Cancer with metastasis.
  • Terminal illness.
  • Language difficulties demanding translator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Research

Roskilde, 4000, Denmark

RECRUITING

Study Officials

  • Knud Rasmussen, MD DMSci

    Region of Zealand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Knud Rasmussen, MD DMSci

CONTACT

Mahad Huniche, Director

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 29, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2015

Study Completion

April 1, 2016

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations