Effects of a HAPA-based Multicomponent Fall Intervention on Older Adults With Declines in Intrinsic Capacity in Nursing Homes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intrinsic capacity (IC) composite score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Intrinsic capacity (IC) composite score
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- The Healthy Aging Instrument (HAI)(baseline, after 16 weeks, after 24 weeks)
研究者
ZHANG Qing-hua
PhD, associate professor
Huzhou Normal University