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Development and Effectiveness of the Occupational Activities Module on the Quality of Life of Older Persons

N

National University of Malaysia

Status

Completed

Conditions

Ageing and Geriatric Health

Treatments

Behavioral: Occupational Activities

Study type

Interventional

Funder types

Other

Identifiers

NCT07251855
JEP-2022-677

Details and patient eligibility

About

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.

Full description

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.

Enrollment

56 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged 60 years and above.
  • Registered member of PAWE.
  • Able to understand and communicate in Malay language.
  • Not involved in the feasibility study.

Exclusion criteria

  • 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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 2 patient groups

Intervention group
Experimental group
Description:
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.
Treatment:
Behavioral: Occupational Activities
Control group
No Intervention group
Description:
The control group not receiving any intervention. The group continued with PAWE's usual activities that has been established prior to the study.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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