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Fall RiskHAPANCT05891782

A HAPA-based Multicomponent Fall Intervention on Older Adults With Declines in Intrinsic Capacity in Nursing Homes

A study testing HAPA-based Multidomain Fall Risk Management and Regular health education lectures in people with Fall Risk, run by ZHANG Qing-hua at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Falls are a common geriatric syndrome that impedes healthy aging and are the primary cause of accidental death in older adults. Globally, more than 50% of older adults experience falls in nursing homes each year. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Fall Risk
What is being tested?
HAPA-based Multidomain Fall Risk Management and Regular health education lectures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 60 years.
  • Living in the nursing home for ≥ 3 months.
  • WHO screening tool identifies at least one dimension of decline in IC.
  • Ability to move independently (non-disabled) with a score of ≥ 4 on the SPPB.
  • Voluntary involvement in the trial and informed consent provided by the participant.

Who cannot join

  • Have severe visual or hearing deprivation.
  • Have severe mental impairment or severe cognitive deficits (i.e., severe depression, schizophrenia).
  • Have severe and terminal heart, liver, brain, and kidney disease (i.e., tumors, brain trauma).
  • Other trials received within 6 months prior to the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huzhou Social Welfare Center

    Huzhou, Zhejiang

Other trials in China

About this study

Official title: Effects of a HAPA-based Multicomponent Fall Intervention on Older Adults With Declines in Intrinsic Capacity in Nursing Homes

Falls are a common geriatric syndrome that impedes healthy aging and are the primary cause of accidental death in older adults. Globally, more than 50% of older adults experience falls in nursing homes each year. Intrinsic capacity (IC) is a quantifiable measure of healthy aging, and consists of five dimensions: cognitive, locomotor, vitality, sensory (vision and hearing), and psychological capacity. Decline in IC is an independent factor in the occurrence of falls in older adults. A related theoretical framework indicates that healthy behaviors are the key to enhance IC. The health action process approach (HAPA) has been shown to have positive effects on health behavior promotion. Therefore, the aim of this study is to examine the effect of multidimensional fall management based on HAPA on fall risk, fall efficacy, and healthy aging among older adults with declines in IC in Chinese nursing homes.

Read the detailed description

Method： First, a randomly selected nursing home in Huzhou, will be selected for the study using the WHO Intrinsic Ability Screening Scale for older adults with declines in IC. A baseline assessment will be conducted followed by clustered randomization to divide into an intervention group (n=50) and a control group (n=50). All subjects will be intervened, after signing the informed consent. The subjects will be assessed by blinded evaluators for primary and secondary outcomes at at study baseline (T0), 4 weeks for the intention intervention (T1), 12 weeks for the action intervention (T2), and 8 weeks for the follow-up (T3). Finally, data collection and statistical processing will be carried out.

Expected results:

Reduce falls risk among the nursing home residents of the intervention group. Improvement of IG among the intervention group. Improvement of healthy aging among the intervention group.

Conditions
Fall Risk
Being tested
HAPA-based Multidomain Fall Risk Management, Regular health education lectures
Keywords
Elderly, Nursing homes, Health behavior promotion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HAPA-based Multidomain Fall Risk ManagementBehavioural

    Also called HAPA-MFRM

    According to the HAPA and the conceptual model of IC, this intervention consists of 3 stages.

    Stage 1: The main format will be group lectures and scenario simulation, each intervention will have a duration of 30 to 45 minutes. Intervention content will utilize BCT [5.1, 5.3, 5.5, 5.6, 9.3, 15.1] .

    Stage 2: This stage will utilize mostly group lectures or one-to-one interviews, to provide an action and coping plan to participants for fall risk management. This will apply BCT [1.1-1.4, 4.1] at week 4.Firstly, individualized targets will be established. Secondly, professionals and participants will collaborate to develop an implementation plan.

    Stage 3:Recovery self-efficacy will be implemented as group discussions, with each intervention lasting 15-30 minutes. Maintenance will be implemented in one-to-one interviews, with each intervention lasting 15-30 minutes.Finally, the consolidation and outlook will provide the foundation for the habit formation of healthy behaviors.

  • Regular health education lecturesBehavioural

    Also called Usual care

    Weeks 1-4 will be provided with fall-related regular health education lectures. Weeks 5-16 will have regular activities according to the daily arrangement of the nursing home. Meanwhile, telephone, WeChat, or face-to-face interviews will be conducted fortnightly, to understand the needs of the participants. During the process, staff will provide usual care such as vital signs monitoring, disease treatment, medication prescription, and health record maintenance.

Study groups in NCT05891782
Study groupRoleWhat they receive
Intervention groupExperimentalA HAPA-based multicomponent fall intervention will use group education, individualized plans and face-to-face interviews to develop health behaviors, such as fall emergency management, IC enhancement (exercise management, diet management, cognitive improvement, psychological regulation, vision protection), medication and disease management, environmental improvement, and fall self-efficacy enhancement.
Receives: Behavioral: HAPA-based Multidomain Fall Risk Management
Control GroupExperimentalThe control group will receive the same overall duration and frequency of interventions as the intervention group.
Receives: Behavioral: Regular health education lectures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intrinsic capacity (IC) composite score

    Each dimension of capability will be assigned score of 1, so the composite score ranges from 0-5, with higher scores representing a decline in IC

    Measured: baseline, after 4 weeks, after 16 weeks, after 24 weeks

  2. The Mini-mental State Examination (MMSE)

    MMSE is a widely used assessment instrument with a score range of 0-30, and the Cronbach's alpha coefficient was 0.833 for internal consistency. Subject to age and culture, the normal thresholds are classified according to the education level, the classification criteria are: illiterate > 17, primary > 20, high school and above > 24 as cognitive normal.

    Measured: baseline, after 4 weeks, after 16 weeks, after 24 weeks

  3. The Short Physical Performance Battery (SPPB)

    SPPB as a recommended physical performance test, combines the balance test, the gait speed test, and the chair rise test. The total scores range from 0 (worst performance) to 12 (best performance), and the Cronbach's alpha coefficient was 0.76 for internal consistency.

    Measured: baseline, after 4 weeks, after 16 weeks, after 24 weeks

  4. The Mini-Nutritional Assessment (MNA)

    MNA is suitable for assessing the vitality of older people, covering anthropometric indicators, dietary and subjective assessments. The total score of the scale is 30, 24-30 is considered good nutritional status, 17-23.5 is at risk of malnutrition, and <17 is considered malnutrition. And the Cronbach's alpha coefficient was 0.71 for internal consistency.

    Measured: baseline, after 4 weeks, after 16 weeks, after 24 weeks

  5. Sensory capacity assessment

    Visual capacity will use the self-report (one item of the WHO ICOPE screening tool) format. If the participant denies visual impairment, a tumbling E chart will be used to standardize visual testing. According to the Standard for Logarithmic Visual Acuity Charts (GB11533-2011), the decimal record will be used. Hearing capacity will use the self-report (two items of the WHO ICOPE screening tool). If the participant denies hearing impairment, a whisper voice test will be used. The examiner will stand behind the participant at an arm's length (0.6 meters). The examiner will whisper common and unrelated four words, and the participant will be required to repeat the words.

    Measured: baseline, after 4 weeks, after 16 weeks, after 24 weeks

  6. The Patient Health Questionnaire-9 (PHQ-9)

    PHQ-9 will assess the frequency of nine depressive symptoms over the past two weeks. The scale has a total score range of 0-27, with scores of 5 and above considering observation or counseling. And the Cronbach's alpha coefficient was 0.82 for internal consistency.

    Measured: baseline, after 4 weeks, after 16 weeks, after 24 weeks

  7. The Self-Rated Fall Risk Questionnaire (SFRQ)

    FRQ was developed by the CDC, which contains 12 items totaling 14 scores, with a score of ≥4 suggesting a risk of falling, and the Cronbach's alpha coefficient was 0.724 for internal consistency.

    Measured: baseline, after 4 weeks, after 16 weeks, after 24 weeks

Secondary outcomes (6)

  1. Timed-Up-and-Go Test (TUG)

    TUG assesses gait and balance in older adults. The participant will sit on the chair, and when the command "start" is heard, they will walk forward as fast as possible to 3 meters, then turn around and walk back to the chair.

    Measured: baseline, after 16 weeks, after 24 weeks

  2. Hand Grip Strength (HGS)

    HGS will be tested using a hand dynamometer (CAMRY). Participants will be required to rest for at least 1 minute before having their grip strength measured. Measurements will be taken in a seated position and dominant hand, with the elbow angle at 90° and the forearm in a neutral position. A maximal squeeze will be performed during the measurement, maintaining body posture, and averaged over three times.

    Measured: baseline, after 16 weeks, after 24 weeks

  3. The Modified Falls Efficacy Scale (MFES)

    MFES was revised in 1996 by Keith Hill et al . The scale is suitable for measuring FOF and activity balance confidence. It consists of 14 items (9 indoor activities and 5 outdoor activities), each of which can be selected on a scale of 0-10, and the Cronbach's alpha coefficient was 0.974 for internal consistency.

    Measured: baseline, after 4 weeks, after 16 weeks, after 24 weeks

  4. The self-management abilities for fall prevention in elderly questionnaire

    It was developed by Huang et al in 2017. The questionnaire contains 7 dimensions with 42 items, the total score ranges from 42 to 210, and the Cronbach's alpha coefficient of the questionnaire is 0.775.

    Measured: baseline, after 4 weeks, after 16 weeks, after 24 weeks

  5. The Fall Management Behavior Change Stage Assessment

    It was developed based on Lippke et al. This scale consists of only one entry: Do you follow the principles of "appropriate exercise, proper diet, emotional adjustment, cognitive improvement, visual and auditory improvement, management of illness and medication, and environmental screening" for fall risk management? Participants selected "No, I have no intention to start falls risk management at this time" for the pre-intention stage; "No, but I have decided to start falls risk management" for the intention stage; and "Yes" for the action stage. The scale had a retest reliability of 0.851.

    Measured: baseline, after 4 weeks, after 16 weeks, after 24 weeks

  6. The Healthy Aging Instrument (HAI)

    The scale covers 9 domains: living a sufficient and simple life, acceptance of aging, stress management, having social relationships and support, helping others, self-care, normal physical functioning, normal cognitive functioning, and social participation. The 35-item scale has a total score of 35-175, with higher scores indicating better levels of healthy aging.

    Measured: baseline, after 16 weeks, after 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study start1 Dec 2023
  3. Primary completion20 Nov 2024
  4. Study completion30 Dec 2024

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study was planned as a randomized controlled clinical trial; by clustered randomization method, cases will be divided into two groups. There are 100 older adults in the nursing home to be studied. Study was planned as group 1 and group 2. The subjects will be assessed by blinded evaluators for primary and secondary outcomes at study baseline (T0), 4 weeks for the intention intervention (T1), 12 weeks for the action intervention (T2), and 8 weeks for the follow-up (T3).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05891782
Sponsor's protocol ID
HuzhouU
Acronym
HAPA
Status last verified
Feb 2025
First submitted
16 May 2023
Last updated
3 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Beard JR, Officer AM, Cassels AK. The World Report on Ageing and Health. Gerontologist. 2016 Apr;56 Suppl 2:S163-6. doi: 10.1093/geront/gnw037. No abstract available.

    PubMed 26994257

  • Zhou Y, Ma L. Intrinsic Capacity in Older Adults: Recent Advances. Aging Dis. 2022 Apr 1;13(2):353-359. doi: 10.14336/AD.2021.0818. eCollection 2022 Apr.

    PubMed 35371613

  • Chhetri JK, Xue QL, Ma L, Chan P, Varadhan R. Intrinsic Capacity as a Determinant of Physical Resilience in Older Adults. J Nutr Health Aging. 2021;25(8):1006-1011. doi: 10.1007/s12603-021-1629-z.

    PubMed 34545921

  • Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.

    PubMed 21767036

  • Treacy D, Hassett L. The Short Physical Performance Battery. J Physiother. 2018 Jan;64(1):61. doi: 10.1016/j.jphys.2017.04.002. Epub 2017 Jun 20. No abstract available.

    PubMed 28645532

  • Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.

    PubMed 9990575

  • Xia NG, Lin JH, Ding SQ, Dong FR, Shen JZ, Du YR, Wang XS, Chen YY, Zhu ZG, Zheng RY, Xu HQ. Reliability and validity of the Chinese version of the Patient Health Questionnaire 9 (C-PHQ-9) in patients with epilepsy. Epilepsy Behav. 2019 Jun;95:65-69. doi: 10.1016/j.yebeh.2019.03.049. Epub 2019 Apr 24.

    PubMed 31026785

  • Lach HW, Ball LJ, Birge SJ. The Nursing Home Falls Self-Efficacy Scale: development and testing. Clin Nurs Res. 2012 Feb;21(1):79-91. doi: 10.1177/1054773811426927. Epub 2011 Oct 31.

    PubMed 22042908

  • Thanakwang K, Soonthorndhada K. Mechanisms by which social support networks influence healthy aging among Thai community-dwelling elderly. J Aging Health. 2011 Dec;23(8):1352-78. doi: 10.1177/0898264311418503. Epub 2011 Aug 23.

    PubMed 21862701

  • Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.

    PubMed 3944402

  • Shang S, Cheng S, Qi L, Liu T, Yang Y, Yao X, Lu D, Cheng X, Yang J, Cheng M, Zhang Q. Effectiveness of HAPA-based multidomain fall risk management for older adults with declining intrinsic capacity in nursing homes: protocol of a randomised controlled trial. BMJ Open. 2025 Apr 30;15(4):e082702. doi: 10.1136/bmjopen-2023-082702.

    PubMed 40306996

Questions about this trial

What is this clinical trial studying?

A study testing HAPA-based Multidomain Fall Risk Management and Regular health education lectures in people with Fall Risk, run by ZHANG Qing-hua 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 5 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 3 Mar 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?

Intrinsic capacity (IC) composite score (time frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks). The study lists 7 primary outcomes in all. 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 NCT05891782, which also lists 11 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 3 Mar 2025.

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