Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors

NCT ID: NCT05519280

Last Updated: 2022-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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Background: Traditionally, biomedical care approach has been insufficient to meet the complex needs of older people living with multi-morbidity. Promoting whole-person wellness and better quality of life becomes a key goal of care in residential long-term care facilities. The integrative approaches composed of physio-psycho-social and spiritual components might be a viable strategy to assist older adults accept uncontrollable life changes and enhance holistic wellness.

Purpose: The study purpose was to develop and evaluate the effects of 8-week biopsychosocial-spiritual (BPS-S) group intervention versus usual care on self-perception of quality of life (QoL) and meaning in life among seniors with disability in residential care home at mid- and post-intervention, and at a 1-month follow up.

Methods: This single-blind randomized controlled trail with repeated measures design was conducted in residential long-term care facilities. Both the experimental groups (EG) and the control group (CG) received routing group activities based on their institution's schedule. Additionally, the EG received 8 sessions of weekly BPS-S group therapy for 80 minutes each. The baseline characteristics of residents with disabilities (including demographic information, length of stay in the institution and medical conditions) were collected using a data sheet, and activities of daily living of these residents were measured using the Barthel Index. To evaluate the effectiveness of the BPS-S group therapy, the primary outcomes including "participants' overall QOL" and the secondary outcome "meaning in life" were assessed at four time points: before, mid- and post- intervention and at a 1-month follow up. Quality of Life Index (QLI)-Part I and Purpose in Life (PIL) test were used to measure these outcome variables, respectively.

Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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the Biopsychosocial-Spiritual Group Intervention

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

Group Type EXPERIMENTAL

the Biopsychosocial-Spiritual Group Intervention

Intervention Type BEHAVIORAL

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

weekly general chatting activities

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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the Biopsychosocial-Spiritual Group Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

have the diagnosis of major depression.
Minimum Eligible Age

65 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mackay Medical College

OTHER

Sponsor Role lead

Responsible Party

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Chin-Tsung Shen

The Office of Research and Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi-Heng Chen

Role: PRINCIPAL_INVESTIGATOR

Department of Nursing

Locations

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Department of Nursing

New Taipei City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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MOST-105-2314-B-715-002-MY3

Identifier Type: -

Identifier Source: org_study_id

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