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

NCT05891782 | Completed

• 1 other identifier: HuzhouU
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fall Risk

Keywords

Elderly; Nursing homes; Health behavior promotion

Outcome Measures

Primary Outcomes (7)

• 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

  baseline, after 4 weeks, after 16 weeks, after 24 weeks

• 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.

  baseline, after 4 weeks, after 16 weeks, after 24 weeks

• 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.

  baseline, after 4 weeks, after 16 weeks, after 24 weeks

• 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.

  baseline, after 4 weeks, after 16 weeks, after 24 weeks

• 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.

  baseline, after 4 weeks, after 16 weeks, after 24 weeks

• 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.

  baseline, after 4 weeks, after 16 weeks, after 24 weeks

• 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.

  baseline, after 4 weeks, after 16 weeks, after 24 weeks

Secondary Outcomes (6)

• Timed-Up-and-Go Test (TUG)

  baseline, after 16 weeks, after 24 weeks

• Hand Grip Strength (HGS)

  baseline, after 16 weeks, after 24 weeks

• The Modified Falls Efficacy Scale (MFES)

  baseline, after 4 weeks, after 16 weeks, after 24 weeks

• The self-management abilities for fall prevention in elderly questionnaire

  baseline, after 4 weeks, after 16 weeks, after 24 weeks

• The Fall Management Behavior Change Stage Assessment

  baseline, after 4 weeks, after 16 weeks, after 24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

A 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.

Behavioral: HAPA-based Multidomain Fall Risk Management

Control Group

EXPERIMENTAL

The control group will receive the same overall duration and frequency of interventions as the intervention group.

Behavioral: Regular health education lectures

Interventions

HAPA-based Multidomain Fall Risk Management BEHAVIORAL

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.

Also known as: HAPA-MFRM

Intervention group

Regular health education lectures BEHAVIORAL

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.

Also known as: Usual care

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• (4) Voluntary involvement in the trial and informed consent provided by the participant.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZHANG Qing-hua: lead

Study Sites (1)

Huzhou Social Welfare Center

Huzhou, Zhejiang, China

Location

Related Publications (11)

• 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.

  PMID: 26994257 BACKGROUND

• 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.

  PMID: 35371613 BACKGROUND

• 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.

  PMID: 34545921 BACKGROUND

• 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.

  PMID: 21767036 BACKGROUND

• 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.

  PMID: 28645532 BACKGROUND

• 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.

  PMID: 9990575 BACKGROUND

• 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.

  PMID: 31026785 BACKGROUND

• 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.

  PMID: 22042908 BACKGROUND

• 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.

  PMID: 21862701 BACKGROUND

• 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.

  PMID: 3944402 BACKGROUND

• 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.

  PMID: 40306996 DERIVED

Study Officials

• Qinghua Zhang, PhD

  School of Medicine & Nursing Sciences, Huzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, associate professor

Model Details: 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).

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 7, 2023
• Study Start: December 1, 2023
• Primary Completion: November 20, 2024
• Study Completion: December 30, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)