Quality of LifeNCT05519280
Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors
A study testing the Biopsychosocial-Spiritual Group Intervention in people with Quality of Life, run by Mackay Medical College at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- the Biopsychosocial-Spiritual Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- have the diagnosis of major depression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors With Disabilities: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Quality of Life
- Being tested
- the Biopsychosocial-Spiritual Group Intervention
- Keywords
- Quality of Life, Institutionalized seniors, Disabilities, Meaning in life, Biopsychosocial-Spiritual group intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Biopsychosocial-Spiritual Group InterventionBehavioural
The Experimental group received 8 sessions of weekly BPS-S group therapy for 80 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| the Biopsychosocial-Spiritual Group Intervention | Experimental | The experimental group received 8 sessions of weekly BPS-S group therapy for 80 minutes each. Receives: Behavioral: the Biopsychosocial-Spiritual Group Intervention |
| weekly general chatting activities | No intervention | The Control group received weekly general chatting activities for 30 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start1 Jan 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin-Tsung Shen, Mackay Medical College
- Investigators
- Yi-Heng Chen, Principal investigator, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519280
- Sponsor's protocol ID
- MOST-105-2314-B-715-002-MY3
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Biopsychosocial-Spiritual Group Intervention on Quality of Life of Institutionalized Seniors With Disabilities: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05519280
- Acronym / sponsor ID
- MOST-105-2314-B-715-002-MY3
- Conditions
- Quality of Life
- Keywords
- Quality of Life, Institutionalized seniors, Disabilities, Meaning in life, Biopsychosocial-Spiritual group intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Mackay Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the Biopsychosocial-Spiritual Group Intervention | Experimental | Behavioral: the Biopsychosocial-Spiritual Group InterventionThe experimental group received 8 sessions of weekly BPS-S group therapy for 80 minutes each. |
| weekly general chatting activities | No intervention | –The Control group received weekly general chatting activities for 30 minutes. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- have the diagnosis of major depression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Biopsychosocial-Spiritual Group InterventionThe Experimental group received 8 sessions of weekly BPS-S group therapy for 80 minutes each. | Behavioural | the Biopsychosocial-Spiritual Group Intervention |
Primary outcome
Change in quality of life summary scores before intervention to 4-week post intervention.
Time frame: 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).
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
1 secondary outcome
Change in Meaning in life summary scores before intervention to 4-week post intervention.
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Heng Chen principal investigator
Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Biopsychosocial-Spiritual Group Intervention in people with Quality of Life, run by Mackay Medical College at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life summary scores before intervention to 4-week post intervention. (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.