A HAPA-based Multicomponent Fall Intervention on Older Adults With Declines in Intrinsic Capacity in Nursing Homes
- Conditions
- Fall Risk
- Interventions
- Behavioral: Regular health education lecturesBehavioral: HAPA-based multicomponent fall intervention
- Registration Number
- NCT05891782
- Lead Sponsor
- ZHANG Qing-hua
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Regular health education lectures 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. Intervention group HAPA-based multicomponent fall intervention 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.
- Primary Outcome Measures
Name Time Method Intrinsic capacity (IC) composite score 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
The Mini-mental State Examination (MMSE) 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.
The Patient Health Questionnaire-9 (PHQ-9) 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.
The Short Physical Performance Battery (SPPB) 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.
The Mini-Nutritional Assessment (MNA) 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.
Sensory capacity assessment 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.
The Self-Rated Fall Risk Questionnaire (SFRQ) 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.
- Secondary Outcome Measures
Name Time Method Timed-Up-and-Go Test (TUG) 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.
Hand Grip Strength (HGS) 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.
The Modified Falls Efficacy Scale (MFES) 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.
The self-management abilities for fall prevention in elderly questionnaire 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.
The Fall Management Behavior Change Stage Assessment 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.
The Healthy Aging Instrument (HAI) 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.
Trial Locations
- Locations (1)
Huzhou Social Welfare Center
🇨🇳Huzhou, Zhejiang, China