NCT01843907

Brief Summary

Randomized Clinical Trial (RCT) To investigate and compare the effect of two preventive interventions on readmission rates, loss of functions, quality of life and cost-benefit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

2.4 years

First QC Date

March 20, 2013

Last Update Submit

July 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants who have been readmitted to hospital

    Number of participants who have been readmitted to hospital. Measured 6 months after admission.

    01.03.2013 - 12.31.2014

Secondary Outcomes (3)

  • Mortality

    01.04.2014 - 31.12.2014

  • Functional ability

    31.12.2014

  • Primary Healthcare Services

    01.04.2013 - 31.12.2014

Study Arms (3)

Empowerment

OTHER

Patients in the intervention group 1 receive a communication report which will also be sent to the physician and home care. In communication report includes the results and interpretation and explanation of the measurements in layman's terms. The report also includes relevant and targeted information on pain management, depression among the elderly, dementia and disability in old age and ways to maintain and improve functional capacity. Links and addresses of relevant, local organizations, and networks are also included. The information material is also included in the report sent to the General Practitioner (GP) and home care.

Behavioral: Empowerment

Conversation with Nurse

OTHER

Patients in the intervention group 2 gets clarification and follow-up conversation with a nurse anchored in both medical department and municipalities. The nurse is "blinded" in relation to the patient's screening results. Problems identified in connection therewith are communicated to the GP and home care.

Other: Conversation with nurse

Controle Group

NO INTERVENTION

Patients in the control group are undergoing the same measurements and records at discharge, as the intervention group, but are otherwise receiving treatment and care as usual without further intervention.

Interventions

EmpowermentBEHAVIORAL

To give patients the necessary resources to take care of their own health

Empowerment

To find out, if the nurse, using her ....

Conversation with Nurse

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years or older
  • Living in their own home with no contact to the Municipality, both before and after admission
  • Discharged from Department o105 or the Acute Receiving Unit \<48 hours from admission.

You may not qualify if:

  • Patients with life-threatening disease in the terminal stage
  • Patients who does not speak and understand Danish
  • Patients who are not able to communicate and collaborate, with regards to the measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

DementiaMalnutritionDepressionPain

Interventions

Nurses

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersNutrition DisordersNutritional and Metabolic DiseasesBehavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Tove L. Damsgaard

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

March 20, 2013

First Posted

May 1, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations