Patient Participation in Prevention of Loss of Functions

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Pain; Malnutrition; Dementia
• Intervention / Treatment: Behavioral: Empowerment; Other: Conversation with nurse

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: Empowerment; To give patients the necessary resources to take care of their own health
Other: 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.	Other: Conversation with nurse; To find out, if the nurse, using her ....
No Intervention: Controle Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality. Number of participants, who have died. Measured 6 months after admission.	01.04.2014 - 31.12.2014
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
Primary Healthcare Services	Delivered services in Primary Healthcare. Measured 6 months after admission.	01.04.2013 - 31.12.2014

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Tove L. Damsgaard, Herlev Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: April 28, 2013
• First Posted (Estimate): May 1, 2013

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 30, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: H-1-2012-118