Caregiver BurdenNCT06522516
A Nurse-led Family-oriented Resilience Program for Caregivers of Community-dwelling Dependent Older Adults
A study testing Evidence-based caregiving training, family resilience intervention and usual service in people with Caregiver Burden, run by Central South University at 1 site in China.
Trial summary
This is a 3-arm controlled trial. The participants are caregivers of the community-dwelling dependent older adults. There will be around 105 participants to be recruited and randomly allocated into 3 groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Evidence-based caregiving training, family resilience intervention and usual service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ①The degree of disability of the caregiver is moderate to severe activity of daily living score above;
- The primary caregivers are≥18 years old ;
- The primary caregivers bear the most important care task during care, and the continuous care time are≥3 months ; -④The psychological pain thermometer score of the primary caregivers are≥5 points (the previous cross-sectional survey results showed that when the psychological pain thermometer score of the primary caregivers in disabled elderly are 5 points, the highest Youden index is obtained, and the sensitivity, specificity, positive predictive value, and negative predictive value are also high. Therefore, participants with scores above 5 points are screened as potential research subjects ); -⑤No cognitive impairment or language expression disorders; -⑥The primary caregivers have smart phones and can use them skillfully, and have access to the Internet; -⑦Voluntarily participate in this study and sign an informed consent form.
Who cannot join
- ①Currently participating or having received intervention from other healthcare teams within the past three months;
- There are paid personnel such as nannies participating in the care.
- Those who voluntarily withdrew from the research process;
- During the research process, due to significant adverse events (such as death) involving disabled elderly individuals or primary caregivers, they were unable to continue participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Nursing, Fudan University
Shanghai, Shanghai Municipality, 20023
About this study
Official title: A Nurse-led Family-oriented Resilience Program for Caregivers of Community-dwelling Dependent Older Adults: a Three-arm Controlled Trial
This is a 3-arm controlled trial. The participants are caregivers of the community-dwelling dependent older adults. There will be around 105 participants to be recruited and randomly allocated into 3 groups. Caregiving training group will receive a evidence-based caregiving training delivered via home visit of community nurse. Caregiving training plus family resilience group will additionally receive a structured family resilience intervetion. Control group will receive usual community health care service by nurses. The primary outcomes are caregiving ability, family resilience and psychological distress, and the secondary outcomes are caregiving burden, resilience, coping, social support, and quality of life the caregivers and the older adults. The measurement will be conducted four times at baseline, after, 1-month and 3-month after intervention.
- Conditions
- Caregiver Burden
- Being tested
- Evidence-based caregiving training, family resilience intervention, usual service
- Keywords
- family resilience, caregiver, distress, older adults
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based caregiving trainingBehavioural
This is designed based on evidence of daily living activity ability caregiving, including① Dietary training: guiding caregivers to choose appropriate tableware according to the functional status of disabled elderly people, and training them in eating posture such as changing positions and using tableware; ② Dressing training: guide caregivers to train disabled elderly people on how to put on and take off clothes, shoes, socks, etc.; ③ Personal hygiene training: including washing face, hands, brushing teeth, etc.; ④ Excretion function training: including urination function training and defecation function training; ⑤ Mobile training: including support walking training, cane walking training, etc.; ⑥ Wheelchair training: Guide caregivers to use wheelchairs according to the specific situation of disabled elderly people.
family resilience interventionBehavioural
The intervention will be developed based on the Maccubbin Family Resilience Theory, and Delphi methods. The content will contain 8 topics and be incorporated into caregiving training manual.
usual serviceBehavioural
This means the usual service provided by the local community health center from nurses during bi-weekly home visit.
| Study group | Role | What they receive |
|---|---|---|
| Caregiving training group | Experimental | Caregiving training group will receive an evidence-based caregiving training via manual during nurse home visit. Receives: Behavioral: Evidence-based caregiving training; Behavioral: usual service |
| Caregiving training plus family resilience group | Experimental | Caregiving training plus family resilience group will receive an evidence-based caregiving training and family resilience psychological intervention via manual during nurse home visit Receives: Behavioral: Evidence-based caregiving training; Behavioral: family resilience intervention; Behavioral: usual service |
| Control group | Active comparator | Controlled group will receive usual community service by nurse. Receives: Behavioral: usual service |
What is being measured
The primary outcome is the main question the study is designed to answer.
family resilience
The Walsh Family Resilience Questionnaire Chinese Version (WFRQ-C) is used to measure the level of family resilience of primary caregivers. The questionnaire includes three dimensions and 26 items: family beliefs, communication and resolution, and external support. The questionnaire items are evaluated using a Likert 5-point rating system, with scores ranging from 1 to 5 from "never" to "always". The higher the score, the higher the level of family resilience. The Cronbach's alpha coefficient of the questionnaire is 0.93, with a test-retest reliability of 0.96, indicating good validity.
Measured: There will be 4 measurements, before, immediately after and，1-month, 3-month after the intervention.
psychological distress
Distress thermometer (DT): used to assess the level of psychological distress of primary caregivers. This scale was designed by Roth and translated into China by Tang Lili et al. in 2011. DT is a visual analog scale scale ranging from 0 to 10 points (0 indicates no psychological distress, 10 indicates extreme psychological distress). The reliability of the Chinese version DT retest is r=0.80, and the calibration validity is good.
Measured: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
caregiving ability
Caregiver Task Inventory (FCTI): used to measure the caregiving ability of primary caregivers. This scale consists of 5 dimensions (adapting to caregiver roles, responding to needs and providing assistance, handling personal emotions, evaluating family and community resource professionals, and adjusting life to meet caregiving needs), with a total of 25 items.The total score is 50 points, with higher scores indicating more caregiving difficulties for caregivers. The Cronbach's alpha coefficient of the scale is 0.93, indicating good construct validity.
Measured: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
Secondary outcomes (6)
caregiving burden
The Zarit Burden Inventory (ZBI) is used to measure the caregiving burden of primary caregivers. This scale is a self-assessment scale consisting of two dimensions: personal burden and responsibility burden, with a total of 22 items. The Cronbach's alpha coefficient of this scale is 0.87.
Measured: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
resilience
The Connor Davidson Resilience Scale (CD-RISC) is used to assess the psychological resilience of primary caregivers.The Chinese version of CD-RISC includes 3 dimensions (resilience, strength, and optimism), 25 items, and is rated on a scale of 1-5, with higher scores indicating higher levels of psychological resilience. The Cronbach's alpha coefficient of the scale is 0.91, indicating good criterion related validity.
Measured: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
coping
Simplified Coping Style Questionnaire (SCSQ): used to assess the coping strategies of primary caregivers. This scale was developed by Jie Yaning in 1998. It includes two dimensions (positive coping and negative coping), with 20 items. The positive coping dimension includes items 1-12, and the negative coping dimension includes items 13-20. It is rated on a scale of 0-3 out of 4. The higher the total score of the positive dimension, the more likely the survey respondents are to adopt positive coping methods; The higher the total score of the negative coping dimension, the more inclined the survey respondents are to adopt negative coping strategies. The Cronbach's alpha coefficient of the positive coping style in this scale is 0.89, and the Cronbach's alpha coefficient of the negative coping style is 0.78.
Measured: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
social support
Perceived Social Support Scale (PSSS): used to measure the perceived level of social support among primary caregivers. This scale was developed by Zemit in 1987 and later translated into Chinese by Huang Li et al. and introduced into China. This scale consists of 3 dimensions (family support, friend support, and other support), with a total of 12 items. It uses a 7-point scoring system ranging from 1 to 7, with higher total scores indicating higher levels of social support. The Cronbach's alpha coefficient of this scale is 0.92, indicating good test-retest reliability and construct validity.
Measured: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
Quality of life of caregiver
The European Five Dimensional Five Level (EQ-5D-5L) health scale: used to measure the quality of life of disabled elderly and primary caregivers. This scale was developed by the European Society for Quality of Life and includes a brief descriptive system questionnaire and a visual analog scale. The Cronbach's alpha coefficient of this scale is 0.857, indicating good validity.
Measured: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
Quality of life of older adults
The European Five Dimensional Five Level (EQ-5D-5L) health scale: used to measure the quality of life of disabled elderly and primary caregivers. This scale was developed by the European Society for Quality of Life and includes a brief descriptive system questionnaire and a visual analog scale. The Cronbach's alpha coefficient of this scale is 0.857, indicating good validity.
Measured: There will be 4 measurements, before, immediately after, 1-month, and 3-month after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Dec 2023
- Primary completion30 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies 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
- Model description
- 2 intervention groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Principal investigator, Anni Wang, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522516
- Sponsor's protocol ID
- A family resilience program
- Status last verified
- Feb 2025
- First submitted
- 20 Jul 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nurse-led Family-oriented Resilience Program for Caregivers of Community-dwelling Dependent Older Adults: a Three-arm Controlled Trial
- ClinicalTrials.gov ID
- NCT06522516
- Acronym / sponsor ID
- A family resilience program
- Conditions
- Caregiver Burden
- Keywords
- family resilience, caregiver, distress, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 26 Jul 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.
This is a 3-arm controlled trial. The participants are caregivers of the community-dwelling dependent older adults. There will be around 105 participants to be recruited and randomly allocated into 3 groups. Caregiving training group will receive a evidence-based caregiving training delivered via home visit of community nurse. Caregiving training plus family resilience group will additionally receive a structured family resilience intervetion. Control group will receive usual community health care service by nurses. The primary outcomes are caregiving ability, family resilience and psychological distress, and the secondary outcomes are caregiving burden, resilience, coping, social support, and quality of life the caregivers and the older adults. The measurement will be conducted four times at baseline, after, 1-month and 3-month after intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 2 intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Caregiving training group | Experimental | Behavioral: Evidence-based caregiving training, Behavioral: usual serviceCaregiving training group will receive an evidence-based caregiving training via manual during nurse home visit. |
| Caregiving training plus family resilience group | Experimental | Behavioral: Evidence-based caregiving training, Behavioral: family resilience intervention, Behavioral: usual serviceCaregiving training plus family resilience group will receive an evidence-based caregiving training and family resilience psychological intervention via manual during nurse home visit |
| Control group | Active comparator | Behavioral: usual serviceControlled group will receive usual community service by nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ①The degree of disability of the caregiver is moderate to severe activity of daily living score above;
Key exclusion criteria (4 listed)
- ①Currently participating or having received intervention from other healthcare teams within the past three months;
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 |
|---|---|---|
| Evidence-based caregiving trainingThis is designed based on evidence of daily living activity ability caregiving, including① Dietary training: guiding caregivers to choose appropriate tableware according to the functional status of disabled elderly people, and training them in eating posture such as changing positions and using tableware; ② Dressing training: guide caregivers to train disabled elderly people on how to put on and take off clothes, shoes, socks, etc.; ③ Personal hygiene training: including washing face, hands, brushing teeth, etc.; ④ Excretion function training: including urination function training and defecation function training; ⑤ Mobile training: including support walking training, cane walking training, etc.; ⑥ Wheelchair training: Guide caregivers to use wheelchairs according to the specific situation of disabled elderly people. | Behavioural | Caregiving training group, Caregiving training plus family resilience group |
| family resilience interventionThe intervention will be developed based on the Maccubbin Family Resilience Theory, and Delphi methods. The content will contain 8 topics and be incorporated into caregiving training manual. | Behavioural | Caregiving training plus family resilience group |
| usual serviceThis means the usual service provided by the local community health center from nurses during bi-weekly home visit. | Behavioural | Caregiving training group, Caregiving training plus family resilience group, Control group |
Primary outcome
family resilience
Time frame: There will be 4 measurements, before, immediately after and，1-month, 3-month after the intervention.
The Walsh Family Resilience Questionnaire Chinese Version (WFRQ-C) is used to measure the level of family resilience of primary caregivers. The questionnaire includes three dimensions and 26 items: family beliefs, communication and resolution, and external support. The questionnaire items are evaluated using a Likert 5-point rating system, with scores ranging from 1 to 5 from "never" to "always". The higher the score, the higher the level of family resilience. The Cronbach's alpha coefficient of the questionnaire is 0.93, with a test-retest reliability of 0.96, indicating good validity.
psychological distress
Time frame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
Distress thermometer (DT): used to assess the level of psychological distress of primary caregivers. This scale was designed by Roth and translated into China by Tang Lili et al. in 2011. DT is a visual analog scale scale ranging from 0 to 10 points (0 indicates no psychological distress, 10 indicates extreme psychological distress). The reliability of the Chinese version DT retest is r=0.80, and the calibration validity is good.
caregiving ability
Time frame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
Caregiver Task Inventory (FCTI): used to measure the caregiving ability of primary caregivers. This scale consists of 5 dimensions (adapting to caregiver roles, responding to needs and providing assistance, handling personal emotions, evaluating family and community resource professionals, and adjusting life to meet caregiving needs), with a total of 25 items.The total score is 50 points, with higher scores indicating more caregiving difficulties for caregivers. The Cronbach's alpha coefficient of the scale is 0.93, indicating good construct validity.
6 secondary outcomes
caregiving burden
Time frame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
resilience
Time frame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
coping
Time frame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
social support
Time frame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
Quality of life of caregiver
Time frame: There will be 4 measurements, before, immediately after,1-month, and 3-month after the intervention.
Quality of life of older adults
Time frame: There will be 4 measurements, before, immediately after, 1-month, and 3-month after the intervention.
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 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based caregiving training, family resilience intervention and usual service in people with Caregiver Burden, run by Central South University at 1 site 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 3 inclusion and 4 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 13 Feb 2025. 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 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?
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?
family resilience (time frame: There will be 4 measurements, before, immediately after and，1-month, 3-month after the intervention.). The study lists 3 primary outcomes in all. 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 13 Feb 2025.