Disabilities, PsychologicalNCT06387641
Effects of Life Review Intervention on Meaning in Life Among Older Adults With Disabilities
A study testing Life review and Routine community health services in people with Disabilities, Psychological, run by Bao Huimin at 4 sites in China.
Trial summary
The goal of this interventional study is to learn if life review works to improve the sense of meaning in life in older adults with disabilities who live at home. The main questions it aims to answer are: Does life review enhance the sense of meaning in life of participants? Does life reviews enhance the life… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Disabilities, Psychological
- What is being tested?
- Life review and Routine community health services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesChina
- Study dates
- 25 Mar 2024to 1 Jan 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60 years old
- Conform to the diagnosis of disability
- Those who scored <38 points on the Chinese version of the Meaning of Life Scale (C-MLQ)
- Conscious, able to comprehend the questionnaire, and have the ability to communicate verbally
- Voluntarily participate in the study and sign the informed consent form
Who cannot join
- With cognitive impairment
- Unable to complete the questionnaire due to their physical condition
- Participated in other psychosocial interventions during the same period
Trial locations and contacts
4 sites in 1 country.
China4 sites
Xixi Street Community Health Service Center
Hanzhou, Zhejiang, 310012
Gongchenqiao Street Community Health Service Centre
Hanzhou, Zhejiang, 310015
Baiyang Street Wenchao Community Health Centre
Hanzhou, Zhejiang, 310018
School of Nursing, Hangzhou Normal University
Hanzhou, Zhejiang, 311121
About this study
Official title: Effects of Life Review Intervention on Meaning in Life Among Older Adults With Disabilities:a Randomised Controlled Trial
The goal of this interventional study is to learn if life review works to improve the sense of meaning in life in older adults with disabilities who live at home. The main questions it aims to answer are:
Does life review enhance the sense of meaning in life of participants? Does life reviews enhance the life satisfaction of participants. Does life reviews enhance the quality of life of participants?
Read more
Researchers will compare the life review program to routine community health services to see if the life review intervention program is effective in enhancing the sense of meaning in life of older adults with disabilities who live at home.
Participants will:
Take face-to-face life review interview or routine community health service every week for 6 weeks.
Take the the questionnaire survey before and after the six-week life review intervention.
- Conditions
- Disabilities, Psychological
- Being tested
- Life review, Routine community health services
- Keywords
- meaning in life, life review, older adults, disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life reviewBehavioural
Life review is a process that involves a thorough examination and reflection on one's past experiences, memories, and life events. This process often involves the identification and examination of significant themes, patterns, and lessons learned throughout one's lifespan. Through life review, individuals can gain a deeper understanding of their own identity, values, and beliefs, and how these have shaped their present circumstances and future outlooks. It can serve as a tool for personal growth, self-discovery, and the promotion of a sense of meaning and purpose in life.
Routine community health servicesBehavioural
Routine community health services refer to a comprehensive health care service system that is government-led, community-participated, and guided by superior health institutions. It focuses on grass-roots health institutions and is staffed with general practitioners as the backbone. By rationally utilizing community resources, it provides a series of comprehensive health care services to community residents. These services center on human health, target families as the unit, cover the entire community, and aim to meet the basic health service needs of community residents.
Specifically, routine community health services include the following aspects: Health Education, Prevention and Control, Health Care Services and so on.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants received routine community health services only. Receives: Behavioral: Routine community health services |
| Life Review | Experimental | In addition to regular community health services,participants receive life review interventions life review intervention once a week for 6 weeks, with each session lasting45-60 minutes. Receives: Behavioral: Life review; Behavioral: Routine community health services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Meaning in life on the Meaning in Life Questionnaire (MLQ) at Week6
The MLQ is a validated self-reported instrument assessing for sense of meaning in life, with 10 items and 2 dimensions, using a 7-point Likert scale, ranging from "totally disagree" to "totally agree" on a scale of 1-7, with a total score of 10-70, with higher scores indicating a higher level of sense of meaning in life.
Measured: Baseline and Week6
Secondary outcomes (2)
Change from Baseline in Life satisfaction on the Life Satisfaction In-dex A (LSIA) at Week6
LSIA is a validated self-reported instrument assessing for life satisfaction. This scale has a total score of 20, with higher scores indicating greater life satisfaction.
Measured: Baseline and Week6
Change from Baseline in Quality of life on the 12-Item Short Form Survey (SF-12) at Week6
SF-12 is a validated self-reported instrument assessing for Quality of life. A total of 12 entries covering 8 dimensions in two areas, with a higher total score representing a higher quality of life.
Measured: Baseline and Week6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start25 Mar 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disabilities, PsychologicalStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bao Huimin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bao Huimin, Hangzhou Normal University
- Investigators
- Huimin Bao, Principal investigator, School of Nursing, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387641
- Sponsor's protocol ID
- 2024004
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lan X, Xiao H, Chen Y. Life review for Chinese older adults in nursing homes: cultural acceptance and its effects. Int Psychogeriatr. 2019 Apr;31(4):527-535. doi: 10.1017/S1041610218001084. Epub 2018 Oct 2.
PubMed 30277193Lan X, Xiao H, Chen Y, Zhang X. Effects of Life Review Intervention on Life Satisfaction and Personal Meaning Among Older Adults With Frailty. J Psychosoc Nurs Ment Health Serv. 2018 Jul 1;56(7):30-36. doi: 10.3928/02793695-20180305-01. Epub 2018 Mar 16.
PubMed 29538790Zheng M, Zhang X, Xiao H. Effects of a WeChat-Based Life Review Program for Patients With Digestive System Cancer: 3-Arm Parallel Randomized Controlled Trial. J Med Internet Res. 2022 Aug 25;24(8):e36000. doi: 10.2196/36000.
PubMed 36006665Chen Y, Sun L, Xiao H, Zheng J, Lin X. Evaluation of a WeChat-based Dyadic Life Review Program for people with advanced cancer and family caregivers: A mixed-method feasibility study. Palliat Med. 2022 Mar;36(3):498-509. doi: 10.1177/02692163211066736. Epub 2022 Feb 20.
PubMed 35184629
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Life Review Intervention on Meaning in Life Among Older Adults With Disabilities:a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06387641
- Acronym / sponsor ID
- 2024004
- Conditions
- Disabilities, Psychological
- Keywords
- meaning in life, life review, older adults, disabilities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Bao HuiminUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 29 Apr 2024 (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.
The goal of this interventional study is to learn if life review works to improve the sense of meaning in life in older adults with disabilities who live at home. The main questions it aims to answer are:
Does life review enhance the sense of meaning in life of participants? Does life reviews enhance the life satisfaction of participants. Does life reviews enhance the quality of life of participants?
Researchers will compare the life review program to routine community health services to see if the life review intervention program is effective in enhancing the sense of meaning in life of older adults with disabilities who live at home.
Participants will:
Take face-to-face life review interview or routine community health service every week for 6 weeks.
Take the the questionnaire survey before and after the six-week life review intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Routine community health servicesParticipants received routine community health services only. |
| Life Review | Experimental | Behavioral: Life review, Behavioral: Routine community health servicesIn addition to regular community health services,participants receive life review interventions life review intervention once a week for 6 weeks, with each session lasting45-60 minutes. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥60 years old
- Conform to the diagnosis of disability
- Those who scored <38 points on the Chinese version of the Meaning of Life Scale (C-MLQ)
- Conscious, able to comprehend the questionnaire, and have the ability to communicate verbally
- Voluntarily participate in the study and sign the informed consent form
Key exclusion criteria (3 listed)
- With cognitive impairment
- Unable to complete the questionnaire due to their physical condition
- Participated in other psychosocial interventions during the same period
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 |
|---|---|---|
| Life reviewLife review is a process that involves a thorough examination and reflection on one's past experiences, memories, and life events. This process often involves the identification and examination of significant themes, patterns, and lessons learned throughout one's lifespan. Through life review, individuals can gain a deeper understanding of their own identity, values, and beliefs, and how these have shaped their present circumstances and future outlooks. It can serve as a tool for personal growth, self-discovery, and the promotion of a sense of meaning and purpose in life. | Behavioural | Life Review |
| Routine community health servicesRoutine community health services refer to a comprehensive health care service system that is government-led, community-participated, and guided by superior health institutions. It focuses on grass-roots health institutions and is staffed with general practitioners as the backbone. By rationally utilizing community resources, it provides a series of comprehensive health care services to community residents. These services center on human health, target families as the unit, cover the entire community, and aim to meet the basic health service needs of community residents. Specifically, routine community health services include the following aspects: Health Education, Prevention and Control, Health Care Services and so on. | Behavioural | Control, Life Review |
Primary outcome
Change from Baseline in Meaning in life on the Meaning in Life Questionnaire (MLQ) at Week6
Time frame: Baseline and Week6
The MLQ is a validated self-reported instrument assessing for sense of meaning in life, with 10 items and 2 dimensions, using a 7-point Likert scale, ranging from "totally disagree" to "totally agree" on a scale of 1-7, with a total score of 10-70, with higher scores indicating a higher level of sense of meaning in life.
2 secondary outcomes
Change from Baseline in Life satisfaction on the Life Satisfaction In-dex A (LSIA) at Week6
Time frame: Baseline and Week6
Change from Baseline in Quality of life on the 12-Item Short Form Survey (SF-12) at Week6
Time frame: Baseline and Week6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Background: PubMed 30277193Lan X, Xiao H, Chen Y. Life review for Chinese older adults in nursing homes: cultural acceptance and its effects. Int Psychogeriatr. 2019 Apr;31(4):527-535. doi: 10.1017/S1041610218001084. Epub 2018 Oct 2.
- Background: PubMed 29538790Lan X, Xiao H, Chen Y, Zhang X. Effects of Life Review Intervention on Life Satisfaction and Personal Meaning Among Older Adults With Frailty. J Psychosoc Nurs Ment Health Serv. 2018 Jul 1;56(7):30-36. doi: 10.3928/02793695-20180305-01. Epub 2018 Mar 16.
- Background: PubMed 36006665Zheng M, Zhang X, Xiao H. Effects of a WeChat-Based Life Review Program for Patients With Digestive System Cancer: 3-Arm Parallel Randomized Controlled Trial. J Med Internet Res. 2022 Aug 25;24(8):e36000. doi: 10.2196/36000.
- Background: PubMed 35184629Chen Y, Sun L, Xiao H, Zheng J, Lin X. Evaluation of a WeChat-based Dyadic Life Review Program for people with advanced cancer and family caregivers: A mixed-method feasibility study. Palliat Med. 2022 Mar;36(3):498-509. doi: 10.1177/02692163211066736. Epub 2022 Feb 20.
- 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.
Huimin Bao principal investigator
School of Nursing, Hangzhou Normal University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life review and Routine community health services in people with Disabilities, Psychological, run by Bao Huimin at 4 sites in China.
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 3 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: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. 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?
Results are not available in the source record.
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 from Baseline in Meaning in life on the Meaning in Life Questionnaire (MLQ) at Week6 (time frame: Baseline and Week6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06387641, which also lists 4 linked publications.
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 10 May 2024.