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

Quality of Life Clinical Trial

Official title:

Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors With Disabilities: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05519280
• Other study ID #: MOST-105-2314-B-715-002-MY3
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: August 2022
• Source: Mackay Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life

Intervention

Behavioral:
• the Biopsychosocial-Spiritual Group Intervention
The Experimental group received 8 sessions of weekly BPS-S group therapy for 80 minutes each.

Locations

Country	Name	City	State
Taiwan	Department of Nursing	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Medical College

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Meaning in life summary scores before intervention to 4-week post intervention.	Meaning in life was measured using the Purpose in Life Test (PIL). It is a 20-item scale designed to measure the degree of perceived meaning and purpose in individual life. Each item of the original scale is rated on a seven-point scale along a continuum from one extreme feeling (0) to the opposite feeling (7). However, too many options may be difficult for older adults to make ratings, so the original seven-point scale was modified to a five-point scale in this study, with 3 representing a neutral response. Possible scores range from 20 to 100, where higher scores indicate stronger sense of meaning in 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).