Family Focused Nursing for Elderly Medical Patients

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

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

Study Overview

• Status: Withdrawn
• Conditions: Depression
• Intervention / Treatment: Behavioral: Family Focused Nursing

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hellerup
    • Copenhagen, Hellerup, Denmark, 2900
      • University Hospital Gentofte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as usual; Pharmacological treatment, patient information and counselling according to international and national guidelines by health professionals specialized in elderly medical patients.
Experimental: Family Focused Nursing; Family Focused Nursing and treatment as usual	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.; Other Names: Family; Nursing; Elderly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in time spent between hospitalization	The effect of intervention on secondary outcome are investigated as longitudinal	7 days and 6 months

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: University Hospital, Gentofte, Copenhagen
• Investigators: Principal Investigator: Penille W Perboell, MHSc, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Quality of life; Family functioning; Family Focused Nursing
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: UNR-H-6-2014-109-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No