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Patient Participation in Prevention of Loss of Functions

Primary Purpose

Dementia, Malnutrition, Depression

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Empowerment
Conversation with nurse
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 65 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

No Intervention

Arm Label

Empowerment

Conversation with Nurse

Controle Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality
Mortality. Number of participants, who have died. Measured 6 months after admission.
Functional ability
Measured 3 months after discharge. Functional ability Handgrip-strength 4 second test: Hand- and forearm muscular strength in kg. and 30 second chair stand test: Lower-body muscle strength
Primary Healthcare Services
Delivered services in Primary Healthcare. Measured 6 months after admission.

Full Information

First Posted
March 20, 2013
Last Updated
July 30, 2015
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01843907
Brief Title
Patient Participation in Prevention of Loss of Functions
Official Title
Cross-sectorial Patient Participation in Prevention of Loss of Functions in Older Short-stay Medical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
At baseline: Nutritional status, BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test), quality of life (EQ5D), coping (Sense of Coherence 13 item scale), patient experience (NORPEQ), medication management (MedMaide). At follow-up three months after discharge: BMI and weight, depression (GDS5), dementia (MMSE), pain (Verbal Ranking Scale), muscle strength (hand-grip strength, chair-to-stand-test) and EQ5D. In addition, need for initiated municipal assistance after discharge. Project employee who performs data collection is blinded to the group to which the patient is randomized. The control group Patients in the control group undergo the same measurements and registrations at discharge and 3 - month follow-up, as the intervention groups, but receive otherwise usual treatment and care, and are discharged without further intervention. After six months control patients receive a report comprising the screening results, relevant information material and a cover letter. Patients' GP and municipality care section receive a summary of outcomes, as well as a cover letter. Register data Information on mortality, readmissions and services in primary health care are obtained after 6 months from the National Patient Register, Population Register and municipalities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Malnutrition, Depression, Pain, Quality of Life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empowerment
Arm Type
Other
Arm Description
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.
Arm Title
Conversation with Nurse
Arm Type
Other
Arm Description
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.
Arm Title
Controle Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Empowerment
Intervention Description
To give patients the necessary resources to take care of their own health
Intervention Type
Other
Intervention Name(s)
Conversation with nurse
Intervention Description
To find out, if the nurse, using her ....
Primary Outcome Measure Information:
Title
Number of participants who have been readmitted to hospital
Description
Number of participants who have been readmitted to hospital. Measured 6 months after admission.
Time Frame
01.03.2013 - 12.31.2014
Secondary Outcome Measure Information:
Title
Mortality
Description
Mortality. Number of participants, who have died. Measured 6 months after admission.
Time Frame
01.04.2014 - 31.12.2014
Title
Functional ability
Description
Measured 3 months after discharge. Functional ability Handgrip-strength 4 second test: Hand- and forearm muscular strength in kg. and 30 second chair stand test: Lower-body muscle strength
Time Frame
31.12.2014
Title
Primary Healthcare Services
Description
Delivered services in Primary Healthcare. Measured 6 months after admission.
Time Frame
01.04.2013 - 31.12.2014

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 65 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tove L. Damsgaard
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

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Patient Participation in Prevention of Loss of Functions

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