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

General Information

Title

RCT ID

AEARCTR-0001516

Initial registration date

August 24, 2016

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published

August 24, 2016, 5:45 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country

Taiwan, Province of China

Region

Taipei

Primary Investigator

Name

Ching-Lan Lin

Affiliation

National Cheng Kung University (NCKU) and Hospital

Contact Primary Investigator

Other Primary Investigator(s)

PI Name

Li-Chi Chiang

PI Affiliation

School of Nursing, National Defense Medical Center & China Medical University, Taipei & Taichung, Taiwan

Contact Investigator

PI Name

Hsiu-Ju Lee

PI Affiliation

Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan.

Contact Investigator

Additional Trial Information

Status

Completed

Start date

2010-11-01

End date

2012-07-31

Keywords

Health

Additional Keywords

family-centered care, bipolar disorder (BPD), family function

JEL code(s)

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

Sponsors & Partners

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

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?

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.

Supporting Documents and Materials

IRB