UMIN-CTR Clinical Trial

Public title

The role of a group neuropsychological rehabilitation program in the cognitive and non-cognitive functioning of institutionalized elders

Acronym

Group neuropsychological rehabilitation program in institutionalized elders

Scientific Title

The role of a group neuropsychological rehabilitation program in the cognitive and non-cognitive functioning of institutionalized elders

Scientific Title:Acronym

Group neuropsychological rehabilitation program in institutionalized elders

Region

Europe

Condition

institutionalized elders without cognitive impairment, but at risk of developing so (N/D-r)
institutionalized elders with cognitive impairment no-dementia (CIND)
institutionalized elders with dementia (DE)

Classification by specialty

Geriatrics

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study is aimed at evaluating whether a structured group neuropsychological rehabilitation program is critical to improving cognitive, emotional and functional outcomes in N/D-r, CIND, and DE, compared with institutionalized elders on a waiting list.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Montreal Cognitive Assessment (MoCA)
Frontal Assessment Battery (FAB)
Geriatric Depression Scale (GDS)
Geriatric Anxiety Scale (GAI)
Positive Affect and Negative Affect Scale (PANAS)
Satisfaction With Life Scale (SWLS)
UCLA-Loneliness Scale (UCLA-LS)

Key secondary outcomes

Geriatric Functionality Scale (GFS)

Study type

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Seventy-two elders will be divided into three diagnostic classifications: 1) with N/D-r (n=24); 2) with CIND (n=24) and 3) with DE (n=24).
Afterwards, the elders with N/D-r will be randomly assigned to the two rehabilitation groups (experimental) (n=12; 6+6) and two waiting list groups (control) (n=12; 6+6); elders with CIND will also be randomly distributed into two rehabilitation groups (experimental) (n=12; 6+6) and two waiting list groups (control) (n=12; 6+6); the same with DE elders.
Each elder subgroup (n=6) will take part in 10 sessions and will be evaluated cognitively (in the neuropsychological area) and non-cognitively (in the emotional/psychological and functional areas) at base-line and at the end of the ten sessions (10 weeks).
The neuropsychological rehabilitation program is distributed in ten 90-min. sessions, each one including five exercises from the following domains:
- Enabler exercise orientated to reminiscence (1-10 sessions in which each participant will answer individually to several past events questions, promoting group interaction),
- Attention (1-10 sessions including visual selective attention & verbal tasks),
- Expressive Language (1, 3-5, 8-10 sessions including object naming, phonological and semantic fluency, and verbal comprehension tasks),
- Constructive praxis (2, 5, 7, 9 sessions including reproduction of relatively complex bi-dimensional pictures),
- Immediate Memory (2, 6, 7, 9 sessions including memory tasks),
- Executive functioning (8-10 sessions including inhibition programming, control, and verbal fluency tasks),
- Expressive Language orientated to reality (1-10 sessions including stimulating verbal memory tasks oriented to reality that will promote comprehension of sentences and verbal expression).

Interventions/Control_2

On the waiting list, another 72 seniors, will be assessed twice with an interval of 10 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

Institutionalized elders N/D-r, with CIND, and with DE,
all with expressive-comprehensive communication capacities, able to see and hear well enough to participate.

Key exclusion criteria

Mental illness (e.g., major depression, psychosis), physical illness (e.g., CVA, brain tumor), or sensory illness (e.g., blindness, deafness) that may compromise their involvement in the tasks; use of medication that affects CNS (except cholinesterase inhibitor and/or SSRI).

Target sample size

144

Name of lead principal investigator

1st name
Middle name
Last name	Helena Espirito Santo

Organization

Instituto Superior Miguel Torga

Division name

Psychology

Zip code

Address

Largo da Cruz de Celas, 1, 3000-132, Coimbra, Portugal

TEL

+351-966926933

Email

helenum@gmail.com

Name of contact person

1st name
Middle name
Last name	Helena Espirito Santo

Organization

Instituto Superior Miguel Torga

Division name

Psychology

Zip code

Address

Largo da Cruz de Celas, 1, 3000-132, Coimbra, Portugal

TEL

+351-966926933

Homepage URL

http://helenum.ismt.pt/My_page/Wellcome.html

Email

helenum@gmail.com

Institute

Helena Espirito Santo

Institute

Department

Personal name

Organization

Centro de Estudos da Populacao, Economia e Sociedade

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Portugal

Co-sponsor

Instituto Superior Miguel Torga

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Many elderly institutions from Coimbra district

Date of disclosure of the study information

2014

Year

04

Month

04

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

After the group neuropsychological rehabilitation program, rehabilitated group improved significantly on cognitive (t = 3.5***), executive function (t = 4.1***), and depressive symptoms (t = 1.5 n.s).
The comparison group worsened on cognitive (t = 2.6*), and executive function (t = 2,3*), and depressive symptoms increased (t = 2.5*).
There was a significant effect on MMSE, FAB, and GDS scores, after excluding pre-rehabilitation scores as a covariates [F (1, 81) = 43.98, p <0.001; eta-squared = 0.35; F (1, 80) = 28.37, p <0.001; eta-squared = 0.26; F (1, 79) = 19.66, p <0.001; eta-squared = 0.20].

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2012

Year

02

Month

15

Day

Date of IRB

Anticipated trial start date

2012

Year

04

Month

15

Day

Last follow-up date

2013

Year

11

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

03

Month

30

Day

Last modified on

2014

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015851