Family Focused Nursing for Elderly Medical Patients

Depression Clinical Trial

Official title:

Family-Focused Nursing for Elderly Medical Patients and Their Family: A Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02408081
• Other study ID #: UNR-H-6-2014-109-5
• Status: Withdrawn
• Phase: N/A
• First received: March 31, 2015
• Last updated: October 25, 2017
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2017
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Family Focused Nursing
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.

Locations

Country	Name	City	State
Denmark	University Hospital Gentofte	Copenhagen	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 7 days and 6 months after the intervention
Secondary	Change in family function score on Brief Family Assessment Measure III	The effect of intervention on secondary outcome are investigated as longitudinal	7 days and 6 months
Secondary	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	7 days and 6 months
Secondary	Change in time spent between hospitalization	The effect of intervention on secondary outcome are investigated as longitudinal	7 days and 6 months