NCT05519280

Brief Summary

This study aimed to evaluate the effects of a biopsychosocial-spiritual (BPS-S) Group intervention on quality of life among seniors with disabilities in long-term care residential settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

August 18, 2022

Last Update Submit

August 25, 2022

Conditions

Keywords

Quality of LifeInstitutionalized seniorsDisabilitiesMeaning in lifeBiopsychosocial-Spiritual group intervention

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life summary scores before intervention to 4-week post intervention.

    Quality of life was measured using the Chinese version of the Quality of Life Index (QLI)-Part I. It contains 33 items measuring satisfaction regarding the four domains (health and functioning, social and economic domain, psychological/spiritual wellness, and family). The QLI-Part I is a six-point satisfaction rating scale from very unsatisfied (1) to very satisfied (6). To determine the scores, each satisfaction item is recoded from -0.25 to 0.25, and both the overall and subscale scores of the QLI-Part I calculated by following step by step scoring instructions ranges from 0 to 30; highest values represent better quality of life

    The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).

Secondary Outcomes (1)

  • Change in Meaning in life summary scores before intervention to 4-week post intervention.

    The data were collected before the intervention to week 12: baseline, in the middle of the intervention (the fourth week), at the end of the intervention (the eighth week), and the follow-up four weeks after the intervention (the twelfth week).

Study Arms (2)

the Biopsychosocial-Spiritual Group Intervention

EXPERIMENTAL

The experimental group received 8 sessions of weekly BPS-S group therapy for 80 minutes each.

Behavioral: the Biopsychosocial-Spiritual Group Intervention

weekly general chatting activities

NO INTERVENTION

The Control group received weekly general chatting activities for 30 minutes.

Interventions

The Experimental group received 8 sessions of weekly BPS-S group therapy for 80 minutes each.

the Biopsychosocial-Spiritual Group Intervention

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • being 65 years of age or older;
  • living in the institution for at least 1 month;
  • Barthel Index scores under 90;
  • no hearing, visual impairment and infectious diseases;
  • being able to follow instructions and participate in group activities.

You may not qualify if:

  • have the diagnosis of major depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nursing

New Taipei City, Taiwan

Location

Study Officials

  • Yi-Heng Chen

    Department of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Office of Research and Development

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 29, 2022

Study Start

January 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations