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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05187572
Other study ID # TRvsCS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2017
Est. completion date June 6, 2017

Study information

Verified date January 2022
Source Escola Superior de Enfermagem de Coimbra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although data suggest that non-pharmacologic therapies such as Reminiscence Therapy (RT) and Cognitive Stimulation (CS) can potentially maintain or reverse this trend, cognitive impairment can be a precursor to neurodegenerative processes. This study aimed to assess how an RT and a CS program affected cognition, depressive symptomatology, and quality of life (QoL) in older persons with cognitive decline who attended community support institutions in central Portugal. For seven weeks, a quasi-experimental study with two arms (RT and CS program) was conducted. The intervention was completed by 76 of the 109 older persons who were first screened (50 in the RT program, 26 in the CS program). In both groups, a pre- and post-intervention analysis revealed statistically significant differences in cognition, particularly in older adults' delayed recall ability.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date June 6, 2017
Est. primary completion date June 6, 2017
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Ability to give informed consent before study commencement; - Ability to participate in group activities for a period between 45 to 60 minutes; - No pronounced impairment of their visual and auditory abilities; - Mild to moderate cognitive decline, assessed as a score equal to or below 20 points in the Six-Item Cognitive Impairment Test (6-CIT). Exclusion Criteria: - Unstable clinical condition; - Prescribed with cholinesterase inhibitors and/or antipsychotics during the study period.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Group intervention
This intervention was developed during 14 sessions, held twice a week, with a duration of 45 to 60 minutes each. The sessions were developed as group-based interventions, facilitated by a leader and a co-leader from each community institution.

Locations

Country Name City State
Portugal The Health Sciences Research Unit: Nursing Coimbra

Sponsors (9)

Lead Sponsor Collaborator
Paulo Costa Associação Nacional de Apoio ao Idoso, Centro Social e Paroquial de Carapinheira do Campo, Centro Social Paroquial de Pedrulha, Centro Sociocultural Polivalente de São Martinho, Doce Viver - Residencial Sénior, Bruscos, Junta de Freguesia de Santo António dos Olivais, Obra Social de Torre de Vilela, Santa Casa de Misericórdia de Cantanhede

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in cognition (person with cognitive decline) Measured using the Montreal Cognitive Assessment (MoCA). Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level. Pre-intervention (baseline)
Primary Change in depressive dymptomatology (person with cognitive decline) Measured using the 10-items Geriatric Depression Scale (GDS-10). Scale scores vary between 0 and 10 points; scores equal or above 2 points correspond to a screening diagnosis of depression. Pre-intervention (baseline)
Primary Change in quality of life (person with cognitive decline) Measured using the World Health Organization Quality of Life - module for older adults (WHOQOL-OLD-8). Scale scores vary between 8 and 40 points; higher scores correspond to a higher level of quality of life. Pre-intervention (baseline)
Primary Change in cognition (person with cognitive decline) Measured using the Montreal Cognitive Assessment (MoCA). Scale scores vary between 0 and 30 points; higher scores correspond to a higher cognition level. 8 weeks post baseline
Primary Change in depressive dymptomatology (person with cognitive decline) Measured using the 10-items Geriatric Depression Scale (GDS-10). Scale scores vary between 0 and 10 points; scores equal or above 2 points correspond to a screening diagnosis of depression. 8 weeks post baseline
Primary Change in quality of life (person with cognitive decline) Measured using the World Health Organization Quality of Life - module for older adults (WHOQOL-OLD-8). Scale scores vary between 8 and 40 points; higher scores correspond to a higher level of quality of life. Pre-intervention (baseline), 8 weeks post baseline
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