Patient Participation in Prevention of Loss of Functions

Not Applicable

Completed

• Conditions: Pain; Dementia; Depression; Malnutrition; Quality of Life
• Interventions: Behavioral: Empowerment; Other: Conversation with nurse

• Registration Number: NCT01843907
• Lead Sponsor: Herlev Hospital

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-04-28
• Study First Posted: 2013-05-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empowerment	Empowerment	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.
Conversation with Nurse	Conversation with nurse	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who have been readmitted to hospital	01.03.2013 - 12.31.2014	Number of participants who have been readmitted to hospital. Measured 6 months after admission.

Secondary Outcome Measures

Name	Time	Method
Mortality	01.04.2014 - 31.12.2014	Mortality. Number of participants, who have died. Measured 6 months after admission.
Functional ability	31.12.2014	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	01.04.2013 - 31.12.2014	Delivered services in Primary Healthcare. Measured 6 months after admission.

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark