Clinical trial NCT05891782: A HAPA-based Multicomponent Fall Intervention on Older Adults With Declines in Intrinsic Capacity in Nursing Homes
Official title: Effects of a HAPA-based Multicomponent Fall Intervention on Older Adults With Declines in Intrinsic Capacity in Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Risk
Keywords: Elderly
Nursing homes
Health behavior promotion
Lead sponsor: Huzhou Normal University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 100 older adults in the nursing home to be studied. Study was planned as group 1 and group 2. The subjects will be assessed by blinded evaluators for primary and secondary outcomes 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).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intrinsic capacity (IC) composite score
timeFrame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
measure: The Mini-mental State Examination (MMSE)
timeFrame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
measure: The Short Physical Performance Battery (SPPB)
timeFrame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
measure: The Mini-Nutritional Assessment (MNA)
timeFrame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
measure: Sensory capacity assessment
timeFrame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
measure: The Self-Rated Fall Risk Questionnaire (SFRQ)
timeFrame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
Secondary outcomes:
measure: Timed-Up-and-Go Test (TUG)
timeFrame: baseline, after 16 weeks, after 24 weeks
measure: Hand Grip Strength (HGS)
timeFrame: baseline, after 16 weeks, after 24 weeks
measure: The Modified Falls Efficacy Scale (MFES)
timeFrame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
measure: The self-management abilities for fall prevention in elderly questionnaire
timeFrame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
measure: The Fall Management Behavior Change Stage Assessment
timeFrame: baseline, after 4 weeks, after 16 weeks, after 24 weeks
measure: The Healthy Aging Instrument (HAI)
timeFrame: baseline, after 16 weeks, after 24 weeks
Other outcomes:
Locations:
city: Huzhou
country: China
facility: Huzhou Social Welfare Center
state: Zhejiang
Study officials:
affiliation: School of Medicine & Nursing Sciences, Huzhou University
name: Qinghua Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beard JR, Officer AM, Cassels AK. The World Report on Ageing and Health. Gerontologist. 2016 Apr;56 Suppl 2:S163-6. doi: 10.1093/geront/gnw037. No abstract available.
citation: Zhou Y, Ma L. Intrinsic Capacity in Older Adults: Recent Advances. Aging Dis. 2022 Apr 1;13(2):353-359. doi: 10.14336/AD.2021.0818. eCollection 2022 Apr.
citation: Chhetri JK, Xue QL, Ma L, Chan P, Varadhan R. Intrinsic Capacity as a Determinant of Physical Resilience in Older Adults. J Nutr Health Aging. 2021;25(8):1006-1011. doi: 10.1007/s12603-021-1629-z.
citation: Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.
citation: Treacy D, Hassett L. The Short Physical Performance Battery. J Physiother. 2018 Jan;64(1):61. doi: 10.1016/j.jphys.2017.04.002. Epub 2017 Jun 20. No abstract available.
citation: Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.
citation: Xia NG, Lin JH, Ding SQ, Dong FR, Shen JZ, Du YR, Wang XS, Chen YY, Zhu ZG, Zheng RY, Xu HQ. Reliability and validity of the Chinese version of the Patient Health Questionnaire 9 (C-PHQ-9) in patients with epilepsy. Epilepsy Behav. 2019 Jun;95:65-69. doi: 10.1016/j.yebeh.2019.03.049. Epub 2019 Apr 24.
citation: Lach HW, Ball LJ, Birge SJ. The Nursing Home Falls Self-Efficacy Scale: development and testing. Clin Nurs Res. 2012 Feb;21(1):79-91. doi: 10.1177/1054773811426927. Epub 2011 Oct 31.
citation: Thanakwang K, Soonthorndhada K. Mechanisms by which social support networks influence healthy aging among Thai community-dwelling elderly. J Aging Health. 2011 Dec;23(8):1352-78. doi: 10.1177/0898264311418503. Epub 2011 Aug 23.
citation: Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.