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

July 8, 2023 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

Active, not recruiting

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=60) and a control group (n=60). All subjects will be intervened, after signing the informed consent. The subjects will be assessed by blinded evaluators for primary and secondary outcomes at study entry (T0), 4 weeks for the intention intervention (T1), 12 weeks for the action intervention (T2), and 8 weeks for the following up (T3). Finally, data collection and statistical processing will be carried out.

Expected results:

Reduce the incidence of falls and falls risk among the nursing home residents of the intervention group.

Increase of extremity physical functional ability (balance, gait speed, and grip strength) of the intervention group.

Improvement of IG among the intervention group. Improvement of healthy aging among the intervention group.

Study Type

Interventional

Enrollment (Estimated)

120

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 Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Huzhou, Zhejiang, China
        • Huzhou Pishan Nursing Care facility

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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 65 years old and has lived in Huzhou nursing homes for nearly 3 months;
  • In IC assessment, the decline in at least one dimension (cognitive, locomotor, vitality, sensory, or psychological capacity) ;
  • Ability to move independently (non-disabled) with a score of ≥4 on the SPPB;
  • Volunteer to participate in the study, and sign the informed consent of research willingness.

Exclusion Criteria:

  • Have severe visual, hearing, and speech impairment;
  • Have severe mental impairment or severe cognitive deficits;
  • Have severe and terminal heart, liver, brain, and kidney disease;
  • Other interventions 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 multicomponent fall intervention

According to the HAPA and the conceptual model of IC, this intervention consists of 3 phases: pre-intention phase → intention phase → action phase.

  1. The pre-intention phase: Group lectures will be used, and the intervention is conducted from week 1 to week 3, with a frequency of 2 times per week and a duration of 30-45 minutes per intervention.
  2. The intention phase: Individualized plans will be used, and the intervention is week 4, with an intervention length of 20-30 minutes. By designing action goals and plans in exercise, daily habits, and external improvements, the intention of the study subjects to manage fall risk is clarified.
  3. The action phase: face-to-face interviews will be used, and the intervention keep from week 5 to week 16. It is supplemented with the text tool "Tumbler: A Falls Risk Management Manual for Older Adults in Nursing Homes" to assist participants in removing barriers to action and increasing their subjective motivation to change health behaviors.
Other Names:
  • Falls Risk Management Manual
Experimental: Control Group
Usual care and health education will be provided at the nursing home. In order to avoid an ethical dilemma between the individuals in the control and intervention groups, the related information will be provided for control group at the end of the study.
Behavioral: Regular health education lectures
Conduct regular health education lectures and distribute relevant materials in paper or electronic form. At the same time, follow-up visits is conducted once a month by phone, WeChat or face-to-face, with each visit lasting at least 25-30 minutes. We will understand the questions and needs of the study participants in multiple ways, and provide answers and support. Weekly bulletin board with information about falls.
Other Names:
  • Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Mini-mental State Examination (MMSE)
Time Frame: 24th week
The most influential cognitive ability assessment tool, with scores ranging from 0 to 30, and the classification criteria are: illiterate > 17, primary > 20, junior high school and above > 24 as cognitive normal.
24th week
The Short Physical Performance Battery (SPPB)
Time Frame: 24th week
It includes balance test, walking speed test, and chair stand test, with a total score of 12 points, and each test score ranges from 0-4 points.
24th week
The Mini-Nutritional Assessment (MNA)
Time Frame: 24th week
The scale is used to assess the nutritional status of the elderly. 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.
24th week
Sensory capacity assessment
Time Frame: 24th week
Ask if there are communication difficulties caused by hearing, wearing hearing aids or related diseases, and if they exist, they are directly considered as hearing impaired. Instead, further whispering test was used. Ask if there is a distance difficulty, reading difficulty, eye disease, or currently under medical treatment; if the above problems exist, they are considered to be visually impaired; conversely, further use visual acuity chart tests.
24th week
The Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 24th week
The total score of the scale was 27, and a score of 5 or more was considered as having depressive symptoms.
24th week
The Self-Rated Fall Risk Questionnaire (SRRQ)
Time Frame: 24th week
It is a 12-item scale for older adults. A score of 2 was assigned to items 1 and 2, and 1 to the remaining items, for a total of 14 points, with a score of ≥4 indicating a risk of falling.
24th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Tinetti Performance Oriented Mobility Assessment (POMA)
Time Frame: 24th week
The scale has 8 items with a total score of 12, with higher scores representing higher risk of falls.
24th week
Grip strength
Time Frame: 24th week
It is measured using a calibrated CAMRY grip strength meter. The measurement is performed twice with the dominant hand in a standing position, with the index finger at 90° to the grip of the grip strength meter, and without changing the body posture during the measurement.
24th week
The Nursing Home Falls Self-Efficacy Scale (NHFSS)
Time Frame: 24th week
The items were rated on a 5-point Likert scale, with 1 representing "not at all confident" and "strongly agree", and 5 representing "very confident" and "strongly disagree". The total score is 30, and the higher the score, the higher the fall self-efficacy.
24th week
The Healthy Aging Instrument (HAI)
Time Frame: 24th week
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.
24th week

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)

June 8, 2023

Primary Completion (Estimated)

November 10, 2023

Study Completion (Estimated)

January 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)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 8, 2023

Last Verified

July 1, 2023

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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