NCT05802043

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 25, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
Last Updated

April 6, 2023

Status Verified

January 1, 2023

Enrollment Period

15 days

First QC Date

March 25, 2023

Last Update Submit

March 25, 2023

Conditions

Keywords

Sense of HappinessCognitive Stimulating Interventions

Outcome Measures

Primary Outcomes (1)

  • I) Mini-Mental State Examination (MMS) Scale

    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.

    2 weeks

Secondary Outcomes (1)

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

    2 weeks

Other Outcomes (2)

  • III) Six -Domains Perceived Cognitive Self-Efficacy for Older Adults Structured Interview Questionnaire

    2 weeks

  • IV) The Subjective Happiness Scale (SHS):

    2 weeks

Study Arms (2)

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.

Behavioral: Cognitive Stimulating Interventions

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,

Behavioral: Cognitive Stimulating Interventions

Interventions

a quasi-experimental research design.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 elderly club.

Cognitive Stimulating InterventionsRoutine Club care

Eligibility Criteria

Age60 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Have no depression: score of 0 to 4 using the Geriatric Depression Scale Short Form (GDS\_SF).
  • \. Accept participation in the study. 6. Available at the selected setting during the time of data collection.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Alexandria, 21523, Egypt

Location

Related Publications (4)

  • Apostolo J, Bobrowicz-Campos E, Holland C, Cano A. One small step in frailty research, a giant leap in evidence based practice. JBI Database System Rev Implement Rep. 2018 Jan;16(1):1-3. doi: 10.11124/JBISRIR-2017-003672. No abstract available.

    PMID: 29324548BACKGROUND
  • Coen RF, Flynn B, Rigney E, O'Connor E, Fitzgerald L, Murray C, Dunleavy C, McDonald M, Delaney D, Merriman N, Edgeworth J. Efficacy of a cognitive stimulation therapy programme for people with dementia. Ir J Psychol Med. 2011 Sep;28(3):145-147. doi: 10.1017/S0790966700012131.

    PMID: 30200025BACKGROUND
  • Feng L, Zin Nyunt MS, Gao Q, Feng L, Yap KB, Ng TP. Cognitive Frailty and Adverse Health Outcomes: Findings From the Singapore Longitudinal Ageing Studies (SLAS). J Am Med Dir Assoc. 2017 Mar 1;18(3):252-258. doi: 10.1016/j.jamda.2016.09.015. Epub 2016 Nov 9.

    PMID: 27838339BACKGROUND
  • Kelly ME, Finan S, Lawless M, Scully N, Fitzpatrick J, Quigley M, Tyrrell F, O'Regan A, Devane A. An evaluation of community-based cognitive stimulation therapy: a pilot study with an Irish population of people with dementia. Ir J Psychol Med. 2017 Sep;34(3):157-167. doi: 10.1017/ipm.2016.23.

    PMID: 30115146BACKGROUND

Study Officials

  • Eman Taha, professor

    Egypt Faculty of Nursing Alexandria, Egypt

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2023

First Posted

April 6, 2023

Study Start

January 17, 2023

Primary Completion

February 1, 2023

Study Completion

February 10, 2023

Last Updated

April 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations