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临床试验/NCT05802043
NCT05802043已完成不适用

Cognitive Stimulating Interventions Improve Cognitive Self- Efficacy and Sense of Happiness Among Older Adults

Alexandria University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
I) Mini-Mental State Examination (MMS) Scale

研究概览

简要总结

The present study aims to determine the effect of cognitive stimulation interventions on cognitive self-efficacy and sense of happiness among older adults.

Research hypothesis:

Older adults who receive the cognitive stimulation interventions exhibit higher cognitive self-efficacy and sense of happiness than those who do not receive it.

详细描述

A convenient sample of eighty (80) older adults will be used according Epi info V 7.0 program calculation based on the following statistical parameters ; Population size: 250, expected frequency: 50%, confidence coefficient: 95%, acceptable error: 10%, minimum sample size = 70.

The study will include eighty (80) older adults aged 60 years and more and fulfilling the following criteria:

Inclusion criteria

  1. Aged 60 years and old.
  2. Able to read and write.
  3. Have mild cognitive impairment: score of score of 18-23 based on the Mini Mental State Examination Scale (MMSE).
  4. Have no depression: score of 0 to 4 using the Geriatric Depression Scale Short Form (GDS_SF).
  5. Accept participation in the study. 6. Available at the selected setting during the time of data collection. 7. Have no pronounced impairment of their visual and auditory abilities could affect their participation in the group and make use of most of the materials in the sessions, as determined by the researchers.

The selected study subjects (80) will be randomly assigned to two equal groups of 40 older adults each as flows; Group 1, study group: include older adults who will receive the proposed interventions, cognitive stimulation interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
60 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Aged 60 years and old.
  • •Able to read and write.
  • •Have mild cognitive impairment: score of score of 18-23 based on the Mini Mental State Examination Scale (MMSE).
  • •Have no depression: score of 0 to 4 using the Geriatric Depression Scale Short Form (GDS_SF).
  • •Accept participation in the study.
  • •Available at the selected setting during the time of data collection.

排除标准

  • •Have pronounced impairment of their visual and auditory abilities could affect their participation in the group and make use of most of the materials in the sessions, as determined by the researchers.

研究组 & 干预措施

Cognitive Stimulating Interventions

Experimental

The study interventions will be developed by the researchers based on review of the related literature and with reference to the CST manual (Spector, et al., 2006), and review on Cognitive Stimulation (Woods et al., 2012). The study subjects of group 1, the study group, will receive the proposed interventions, the cognitive stimulation interventions through small groups of study subjects receiving 12 sessions of group activities (2 sessions/week, approximately 45- 60 minutes/session). A group size of 6 to 8 will be conducted. The interventions group will be conducted in activity rooms within the elderl club. The study subjects group 2, the control group, will receive the routine activities of the elderly club. The researchers will provide the control group with written materials related the essential cognitive stimulation interventions after ending the implementation of the proposed interventions for the study group.

干预措施: Cognitive Stimulating Interventions (Behavioral)

Routine Club care

Active Comparator

The study subjects group 2, the control group, will receive the routine activities of the elderly club.The researchers will provide the control group with written materials related the essential cognitive stimulation interventions after ending the implementation of the proposed interventions for the study group,

干预措施: Cognitive Stimulating Interventions (Behavioral)

结局指标

主要结局

I) Mini-Mental State Examination (MMS) Scale

时间窗: 2 weeks

The MMS scale was developed by Folestein et al., (1975). It used to assess cognitive function of the older adults. It contained questions concerning registration, orientation, calculation, recall, attention, and language. The MMS scale score was 30 point and classified as follows: -30. -23. -17. The MMS was translated into Arabic and approved to be valid and reliable (r=0.96) by El Husseini (2008). The Arabic version of this scale was used in the present study.

次要结局

  • II) Geriatric Depression Scale- Short Form (GDS-SF)(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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