Patient Participation in Prevention of Loss of Functions

Depression Clinical Trial

Official title:

Cross-sectorial Patient Participation in Prevention of Loss of Functions in Older Short-stay Medical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843907
• Other study ID #: H-1-2012-118
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: July 30, 2015
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dementia
• Depression
• Malnutrition
• Pain
• Quality of Life

Intervention

Behavioral:
• Empowerment
To give patients the necessary resources to take care of their own health

Other:
• Conversation with nurse
To find out, if the nurse, using her ....

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mortality	Mortality. Number of participants, who have died. Measured 6 months after admission.	01.04.2014 - 31.12.2014	No
Secondary	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	31.12.2014	No
Secondary	Primary Healthcare Services	Delivered services in Primary Healthcare. Measured 6 months after admission.	01.04.2013 - 31.12.2014	No