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

Fall Risk Clinical Trial

— HAPA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05891782
• Other study ID #: HuzhouU
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: July 2023
• Source: Huzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: January 30, 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fall Risk

Intervention

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. 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.
• 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.

Locations

Country	Name	City	State
China	Huzhou Pishan Nursing Care facility	Huzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
ZHANG Qing-hua

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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