x

We are happy to announce that all trial registrations will now be issued DOIs (digital object identifiers). For more information, see here.
A randomized controlled trial of a brief family-centered care program for hospitalized patients with bipolar disorder and their family caregivers
Last registered on August 24, 2016

Pre-Trial

Trial Information
General Information
Title
A randomized controlled trial of a brief family-centered care program for hospitalized patients with bipolar disorder and their family caregivers
RCT ID
AEARCTR-0001516
Initial registration date
August 24, 2016
Last updated
August 24, 2016 5:45 AM EDT
Location(s)
Primary Investigator
Affiliation
National Cheng Kung University (NCKU) and Hospital
Other Primary Investigator(s)
PI Affiliation
School of Nursing, National Defense Medical Center & China Medical University, Taipei & Taichung, Taiwan
PI Affiliation
Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.
Additional Trial Information
Status
Completed
Start date
2010-11-01
End date
2012-07-31
Secondary IDs
Abstract
Because of the bidirectional and entangled relationships between patients with bipolar disorder (BPD) and the family system, using family interventions has been emphasized. However, the effects of family interventions on family function and caregivers’ health-related outcomes have not been well investigated. This randomized controlled trial with 47 hospitalized patient-with-BPD/family-caregiver dyads at a medical center in northern Taiwan compared the effects of a brief family-centered care (BFCC) program with treatment-as-usual (TAU). In the experimental group, four 90-minute BFCC program sessions were provided twice a week for each hospitalized family dyad. Family caregivers in the TAU group were invited to attend a 60-minute family discussion group about violence and suicide prevention without any specific family-nursing intervention. Three outcome indicators—family function, caregivers’ perceived health status, and caregivers’ burden—were assessed at baseline and post-treatment. The BFCC group showed significant time  group interaction effects in overall family function and subscale-conflict, communication, and problem solving (p = 0.009-0.037), but there were no significant interaction effects on the caregivers’ perceived health status and burdens. Our findings support both the feasibility of using the BFCC program for inpatients and its specific benefits for family function. An intensive family intervention during hospitalization has been suggested in psychiatric practice to support patients with BPD and family caregivers.
External Link(s)
Registration Citation
Citation
Chiang, Li-Chi, Hsiu-Ju Lee and Ching-Lan Lin. 2016. "A randomized controlled trial of a brief family-centered care program for hospitalized patients with bipolar disorder and their family caregivers." AEA RCT Registry. August 24. https://doi.org/10.1257/rct.1516-1.0.
Former Citation
Chiang, Li-Chi, Hsiu-Ju Lee and Ching-Lan Lin. 2016. "A randomized controlled trial of a brief family-centered care program for hospitalized patients with bipolar disorder and their family caregivers." AEA RCT Registry. August 24. https://www.socialscienceregistry.org/trials/1516/history/10343.
Experimental Details
Interventions
Intervention(s)
A Brief Family-Centered Care (BFCC) Program for hospitalized patients with BPD and their family caregivers
Intervention Start Date
2011-08-01
Intervention End Date
2011-12-31
Primary Outcomes
Primary Outcomes (end points)
family function, caregivers’ perceived health status, and caregivers’ burden
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Randomized controlled trial
Experimental Design Details
Randomization Method
After their baseline assessments had been completed, patients who met the study’s inclusion criteria and who agreed to participate were randomly assigned to either the BFCC group or the TAU group. The randomization was done by an investigator who used a computerized random number generator. Raters were blinded to the groups to which the patient/caregiver dyads were assigned.
Randomization Unit
Unit of randomization is each individual family dyad.
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
134 patients were screened for enrollment in the study.
Sample size: planned number of observations
37 dyads were observed.
Sample size (or number of clusters) by treatment arms
17 dyads in the BFCC group and 20 dyads in the Treatment As Usual group were analyzed.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Based on conservative considerations—a G*Power analysis (Faul et al. 2007)—to reach an effect size of 0.2 for a new innovative intervention (Perlick et al. 2010) when a= 0.05 and b = 0.80, would require 28 patients to detect differences in repeated measures in a within-between interaction.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Taipei Veterans General Hospital
IRB Approval Date
2011-10-24
IRB Approval Number
201002004IA
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers