Development and Effectiveness of the Occupational Activities Module on the Quality of Life of Older Persons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
研究概览
简要总结
The purpose of this study was to find out whether the Occupational Activities Module (Modul Aktiviti Cara Kerja - MACK) could help older adults stay more active and healthier. The study examined whether participation in the programme using MACK improved how well older adults carried out their daily activities, how strong and fit they felt, and how good their overall quality of life was.
Two groups of older adults took part. One group joined the MACK programme for 14 weeks, while the other group continued with their normal daily routines. Their ability to perform daily activities, physical fitness, and quality of life were measured at the beginning, middle, and end of the study to identify any changes or improvements.
详细描述
This study employed a quantitative Cluster Randomized Trial (CRT) design, suitable for community-based settings such as the Centre for Older Persons (Pusat Aktiviti Warga Emas, PAWE), where interventions are delivered at the organizational level. A modified Stepped Wedge CRT (SW-CRT) was used, in which only the intervention clusters implemented the program in a staggered sequence, while control clusters continued routine PAWE activities throughout the study. This design minimized contamination between groups, addressed logistical constraints, and accommodated the limited number of outcome assessors.
The study population consisted of older adults aged 60 years and above who were registered members of PAWE. Most members were local retirees or non-working residents who remained physically and socially active, seeking opportunities to sustain engagement and wellbeing. Sampling was conducted in two stages: (1) selection of PAWE centers and (2) selection of participants within each center. From 28 PAWE centers in the Klang Valley, eight were randomly selected by ballot and then randomly assigned equally to intervention or control groups (n=4 each). Allocation was performed by an independent blinded individual to ensure allocation concealment.
Participant recruitment combined purposive and convenience sampling. PAWE supervisors were briefed on the study and informed eligible members in person or via WhatsApp. The first 10 interested members were listed and screened for eligibility, and seven were selected through simple randomization using Excel's random number generator, with the remaining three held as reserves. The required sample size, calculated using G*Power for repeated-measures ANOVA (α=0.05, power=0.80, effect size=0.19), was 56 participants, adjusted for 10% dropout. Baseline screening used the Modified Barthel Index (MBI) and Mini-Mental State Examination (MMSE).
Inclusion criteria were aged 60 years and above, registered PAWE member, able to communicate in Malay, and not involved in the feasibility study. Exclusion criteria were diagnosis of degenerative disease (e.g., Alzheimer's, Parkinson's, Huntington's, multiple sclerosis), untreatable vision or hearing impairment, moderate to full dependence in ADLs (MBI ≤ 60), or moderate to severe cognitive impairment (MMSE ≤ 20).
The SW-CRT proceeded in four steps. In week 1, all clusters were in control status and baseline assessments were conducted. Beginning in week 2, intervention clusters initiated the program sequentially after baseline assessments, until by week 4 all four intervention PAWE were actively running the program, while control PAWE continued routine activities until the final assessment at week 15. Assessments were conducted at three time points: baseline (P1), mid-intervention at week 8 (P2), and post-intervention at week 15 (P3). Outcome assessors were blinded to allocation status to minimize bias, although participants could not be blinded due to the nature of the intervention.
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
- Double (Participant, 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
- 是
入选标准
- •Aged 60 years and above.
- •Registered member of PAWE.
- •Able to understand and communicate in Malay language.
- •Not involved in the feasibility study.
排除标准
- •Diagnosed with degenerative diseases (e.g., Alzheimer's, Parkinson's, Hungtinton's, multiple sclerosis).
- •Untreateable vision or hearing impairment.
- •Moderate to full dependence in basic daily activities (MBI score ≤ 60).
- •Moderate to severe cognitive impairment (MMSE score ≤ 20).
研究组 & 干预措施
Intervention group
The intervention arm received the MACK program, a structured activity-based intervention for older adults delivered over 14 weeks, twice weekly (9:00 a.m.-3:00 p.m.). Sessions were held at PAWE.
干预措施: Occupational Activities (Behavioral)
Control group
The control group not receiving any intervention. The group continued with PAWE's usual activities that has been established prior to the study.
结局指标
主要结局
Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
时间窗: Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme
The Lawton Instrumental Activities of Daily Living Scale (Lawton IADL) is used to assess functional ability in performing instrumental activities of daily living, which are more complex than basic daily activities. The instrument evaluates eight domains: ability to use the telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and handling finances. Each domain is scored according to the individual's level of independence, with a total score ranging from 0 to 8. A score of 0 indicates low function with dependence on others, while a score of 8 reflects high function and independence. The scale is simple to administer, can be self-reported, and typically takes 10-15 minutes to complete. It has good inter-item reliability (α = 0.85) and demonstrated validity through significant correlations with other functional status measures.
Bruininks Motor Ability Test (BMAT)
时间窗: Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme
The Bruininks Motor Ability Test (BMAT) is a standardized assessment used to measure fine and gross motor skills in adults aged 40 years and above. These motor abilities are closely related to physical functioning and the capacity to perform daily activities. The test evaluates performance through subtests and composite structures focusing on fine and gross motor aspects such as balance, mobility, strength, coordination, and object manipulation. BMAT comprises comprehensive, stand-alone subtests with established validity, reliability, and sensitivity. Its psychometric properties include test-retest reliability ranging from 0.77 to 0.94, inter-rater reliability between 0.95 and 0.99, and internal consistency values from 0.60 to 0.92. The subtests include fine motor integration, manual dexterity, coordination, balance and mobility, and strength and flexibility.
Older People's Quality of Life Questionnaire - Short Version (OPQOL-Brief)
时间窗: Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme
The Older People's Quality of Life Questionnaire Short Version (OPQOL-Brief) is used to assess the quality of life among older adults. Adapted from the original OPQOL with 35 items, the OPQOL-Brief contains 13 items and has been validated in studies conducted in Britain and Italy. It has shown high reliability and validity when compared with other established instruments such as the World Health Organization Quality-of-Life Scale (WHOQOL) and the CASP-19 (Control, Autonomy, Self-Realization, and Pleasure) questionnaire. The internal consistency of the OPQOL-Brief is strong, with a Cronbach's alpha coefficient of 0.856, comparable to that of the original OPQOL. Each item is scored on a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), with responses reverse-coded for scoring purposes (e.g., 1 = 5, 2 = 4). The maximum possible score is 65, which indicates the highest quality of life, while lower scores reflect poorer quality of life.
Modified Barthel Index
时间窗: Screening of inclusion criteria, Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme
The Modified Barthel Index (MBI) is a tool to assess functional ability in performing basic activities of daily living (ADL). It evaluates 10 essential activities, including transfers from bed to chair, mobility through walking or wheelchair use, stair climbing, toileting, bladder and bowel control, bathing, dressing, grooming, and feeding. Each activity is scored on a scale from 0 to 10, with the total score ranging from 0 to 100. A total score of 100 indicates full independence, 91-99 reflects minimal assistance, 61-91 indicates moderate assistance, 21-60 reflects substantial assistance, and 0-21 indicates complete dependence in daily functioning. The MBI has demonstrated high internal consistency, with a Cronbach's alpha coefficient of 0.92, confirming its reliability as a measure of functional independence among individuals.
Lawton Instrumental Activities of Daily Living Scale (Lawton IADL)
时间窗: Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme
The Lawton Instrumental Activities of Daily Living Scale (Lawton IADL) is used to assess functional ability in performing instrumental activities of daily living, which are more complex than basic daily activities. The instrument evaluates eight domains: ability to use the telephone, shopping, food preparation, housekeeping, laundry, transportation, medication management, and handling finances. Each domain is scored according to the individual's level of independence, with a total score ranging from 0 to 8. A score of 0 indicates low function with dependence on others, while a score of 8 reflects high function and independence. The scale is simple to administer, can be self-reported, and typically takes 10-15 minutes to complete. It has good inter-item reliability (α = 0.85) and demonstrated validity through significant correlations with other functional status measures.
Bruininks Motor Ability Test (BMAT)
时间窗: Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme
The Bruininks Motor Ability Test (BMAT) is a standardized assessment used to measure fine and gross motor skills in adults aged 40 years and above. These motor abilities are closely related to physical functioning and the capacity to perform daily activities. The test evaluates performance through subtests and composite structures focusing on fine and gross motor aspects such as balance, mobility, strength, coordination, and object manipulation. BMAT comprises comprehensive, stand-alone subtests with established validity, reliability, and sensitivity. Its psychometric properties include test-retest reliability ranging from 0.77 to 0.94, inter-rater reliability between 0.95 and 0.99, and internal consistency values from 0.60 to 0.92. The subtests include fine motor integration, manual dexterity, coordination, balance and mobility, and strength and flexibility.
Older People's Quality of Life Questionnaire - Short Version (OPQOL-Brief)
时间窗: Baseline (Before MACK programme), Mid of intervention (Week 8 or after 7 weeks of MACK programme), Post intervention (Week 15 or after 14 weeks of MACK programme
The Older People's Quality of Life Questionnaire Short Version (OPQOL-Brief) is used to assess the quality of life among older adults. Adapted from the original OPQOL with 35 items, the OPQOL-Brief contains 13 items and has been validated in studies conducted in Britain and Italy. It has shown high reliability and validity when compared with other established instruments such as the World Health Organization Quality-of-Life Scale (WHOQOL) and the CASP-19 (Control, Autonomy, Self-Realization, and Pleasure) questionnaire. The internal consistency of the OPQOL-Brief is strong, with a Cronbach's alpha coefficient of 0.856, comparable to that of the original OPQOL. Each item is scored on a five-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), with responses reverse-coded for scoring purposes (e.g., 1 = 5, 2 = 4). The maximum possible score is 65, which indicates the highest quality of life, while lower scores reflect poorer quality of life.
次要结局
未报告次要终点