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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fall Risk

Intervention / Treatment
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* Behavioral: HAPA-based multicomponent fall intervention
* Behavioral: Regular health education lectures


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 120 older adults in the nursing home to be studied. Study was planned as group 1 and group 2. Four weeks after the first measurement, which is the pre-intentional phase and intentional phase of the fall risk intervention, then followed by a second measurement. After the 12-week action phase intervention is finished, the third measurements will be made. After the third measurements, the fourth measurement will be done 4 weeks follow-up later.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* According to the HAPA and the conceptual model of IC, this intervention consists of 3 phases: pre-intention phase → intention phase → action phase. 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. 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. 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.<br>* Other names: Falls Risk Management Manual;|
| Experimental: Control Group<br>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<br>* 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.<br>* Other names: Usual care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Mini-mental State Examination (MMSE) | 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) | 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) | 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 | 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) | 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) | 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) | The scale has 8 items with a total score of 12, with higher scores representing higher risk of falls. | 24th week | 
| Grip strength | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Nursing homes, Health behavior promotion