Clinical trial NCT05519280: Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors
Official title: Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors With Disabilities: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Quality of Life
Institutionalized seniors
Disabilities
Meaning in life
Biopsychosocial-Spiritual group intervention
Lead sponsor: Mackay Medical College
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 83
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in quality of life summary scores before intervention to 4-week post intervention.
timeFrame: 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:
measure: Change in Meaning in life summary scores before intervention to 4-week post intervention.
timeFrame: 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).
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Department of Nursing
Study officials:
affiliation: Department of Nursing
name: Yi-Heng Chen
role: PRINCIPAL_INVESTIGATOR
References: