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Family Focused Nursing for Elderly Medical Patients

Primary Purpose

Depression

Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Family Focused Nursing
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring Depression, Family functioning, Family Focused Nursing, Quality of life

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute hospitalized
  • an expected hospitalization of minimum two days
  • speak and understand Danish
  • signed informed consent

Exclusion Criteria:

  • dementia (evaluated by the Mini Mental State Examination [MMSE] < 24)
  • terminally ill patients whose survival rate is assessed to be less than a month

Sites / Locations

  • University Hospital Gentofte

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as usual

Family Focused Nursing

Arm Description

Pharmacological treatment, patient information and counselling according to international and national guidelines by health professionals specialized in elderly medical patients.

Family Focused Nursing and treatment as usual

Outcomes

Primary Outcome Measures

Change in depressive symptoms assessed by 9 points measured on the Geriatric Depression Scale
The effect of intervention on primary outcome are investigated as longitudinal data at seven days and six month. The data are analysed using mixed models

Secondary Outcome Measures

Change in family function score on Brief Family Assessment Measure III
The effect of intervention on secondary outcome are investigated as longitudinal
Change in health related quality of life on Medical Outcomes Study Short Form, SF-8
The effect of intervention on secondary outcome are investigated as longitudinal
Change in time spent between hospitalization
The effect of intervention on secondary outcome are investigated as longitudinal

Full Information

First Posted
March 31, 2015
Last Updated
October 25, 2017
Sponsor
University of Southern Denmark
Collaborators
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02408081
Brief Title
Family Focused Nursing for Elderly Medical Patients
Official Title
Family-Focused Nursing for Elderly Medical Patients and Their Family: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
not able to be completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
University Hospital, Gentofte, Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether Family Focused Nursing are effective in the treatment of elderly medical patients with respect to prevalence of depression
Detailed Description
Psychosocial issues such as lack of social support and symptoms of depression, are risk factors associated to readmission for elderly medical patients. Families with elderly members in general want to be involved in the caring and want to maintain a close relation to their elderly family member. However, disease in a single family can have a negative effect on all members and may result in dysfunction of the family. International guidelines recommend that the patient's relatives are involved in patient education as well as the treatment. Family interventions might contribute to decline depression and readmissions, besides enhanced quality of life and family function among elderly medical patients and their next of kin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Family functioning, Family Focused Nursing, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Pharmacological treatment, patient information and counselling according to international and national guidelines by health professionals specialized in elderly medical patients.
Arm Title
Family Focused Nursing
Arm Type
Experimental
Arm Description
Family Focused Nursing and treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Family Focused Nursing
Other Intervention Name(s)
Family, Nursing, Elderly
Intervention Description
All patients receive treatment as usual. Additionally, patients in the intervention arm receives family focused nursing consultations which are structured as sessions focusing on change, improvement and/or maintenance of family function within cognitive, affective and behavioral knowledge. Each session is organized and individualized according to the wishes and needs for education and counseling of the families within a period of one months.
Primary Outcome Measure Information:
Title
Change in depressive symptoms assessed by 9 points measured on the Geriatric Depression Scale
Description
The effect of intervention on primary outcome are investigated as longitudinal data at seven days and six month. The data are analysed using mixed models
Time Frame
Baseline, 7 days and 6 months after the intervention
Secondary Outcome Measure Information:
Title
Change in family function score on Brief Family Assessment Measure III
Description
The effect of intervention on secondary outcome are investigated as longitudinal
Time Frame
7 days and 6 months
Title
Change in health related quality of life on Medical Outcomes Study Short Form, SF-8
Description
The effect of intervention on secondary outcome are investigated as longitudinal
Time Frame
7 days and 6 months
Title
Change in time spent between hospitalization
Description
The effect of intervention on secondary outcome are investigated as longitudinal
Time Frame
7 days and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: acute hospitalized an expected hospitalization of minimum two days speak and understand Danish signed informed consent Exclusion Criteria: dementia (evaluated by the Mini Mental State Examination [MMSE] < 24) terminally ill patients whose survival rate is assessed to be less than a month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penille W Perboell, MHSc
Organizational Affiliation
University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Gentofte
City
Copenhagen
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Family Focused Nursing for Elderly Medical Patients

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