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

February 26, 2025 updated by: ZHANG Qing-hua

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Huzhou, Zhejiang, China
        • Huzhou Social Welfare Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 60 years.
  2. Living in the nursing home for ≥ 3 months.
  3. WHO screening tool identifies at least one dimension of decline in IC.
  4. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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

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.

Other Names:
  • HAPA-MFRM
Experimental: Control Group
The control group will receive the same overall duration and frequency of interventions as the intervention group.
Behavioral: Regular health education lectures
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.
Other Names:
  • Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrinsic capacity (IC) composite score
Time Frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
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)
Time Frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
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)
Time Frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
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)
Time Frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
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
Time Frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
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)
Time Frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
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)
Time Frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed-Up-and-Go Test (TUG)
Time Frame: baseline, after 16 weeks, after 24 weeks
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.
baseline, after 16 weeks, after 24 weeks
Hand Grip Strength (HGS)
Time Frame: baseline, after 16 weeks, after 24 weeks
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.
baseline, after 16 weeks, after 24 weeks
The Modified Falls Efficacy Scale (MFES)
Time Frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
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.
baseline, after 4 weeks, after 16 weeks, after 24 weeks
The self-management abilities for fall prevention in elderly questionnaire
Time Frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
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.
baseline, after 4 weeks, after 16 weeks, after 24 weeks
The Fall Management Behavior Change Stage Assessment
Time Frame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
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.
baseline, after 4 weeks, after 16 weeks, after 24 weeks
The Healthy Aging Instrument (HAI)
Time Frame: baseline, after 16 weeks, after 24 weeks
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.
baseline, after 16 weeks, after 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
WHO ICOPE screening tool:
Time Frame: Enrollment
To include participants with declining IC, the tool will be used following the standardized process of the WHO ICOPE guideline. The tool consists of cognitive (1 item), locomotor (1 item), vitality (2 items), sensory (2 hearing and 1 vision item), and psychological (2 items), identifying dimensions of decline that will be further measured.
Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZHANG Qing-hua

Investigators

  • Principal Investigator: Qinghua Zhang, PhD, School of Medicine & Nursing Sciences, Huzhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

November 20, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HuzhouU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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