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Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty (ECOG_CS)

Primary Purpose

Neurocognitive Disorders, Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Individual Cognitive Stimulation Therapy Program
Sponsored by
Escola Superior de Enfermagem de Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neurocognitive Disorders

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elderly person with 60 years of age or older;
  • Diagnosis of mild or major neurocognitive disorder, performed by a physician specialized in neurology or psychiatry, or who is validated by the family physician in accordance with DSMIII/IV/5 or ICD-9/10 criteria;
  • Presence of mild to moderate cognitive impairment according to the 6-Item Cognitive Decline Test (6CIT);
  • Capable of communicating and understanding communication;
  • Without a physical illness or significant disability (eg elderly people who are on dialysis or bedridden);
  • Living in the community (in their home);
  • Have an informal caregiver available and able to develop the individual cognitive stimulation program.

Exclusion Criteria:

  • Elderly / informal caregiver with a history of severe psychiatric illness diagnosed before 60 years of age;
  • Informal caregiver with cognitive impairment, even if mild (mild PNC according to DSM-5 criteria);
  • Elderly people who do not live in their home.

Sites / Locations

  • Health Sciences Research Unit: Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Individual Cognitive Stimulation Therapy

Arm Description

The control group shall participate in the usual home-based care provided by their carer.

The experimental group shall participate in the Making a Difference 3 program (Yates et al., 2015) is aimed at elderly people with mild or major neurocognitive disorder, where informal caregiver (family, friend or neighbour) assume a partnering role in an one-to-one approach. The program is composed by a range of stimulating activities (sessions), each with two levels of difficulty. The carers are introduced to a set of key principles that guides them during individual cognitive stimulation sessions, tailoring the interventions to the needs and reality of the elderly participants.

Outcomes

Primary Outcome Measures

Change from Baseline in the elderly participant's Cognition
Outcome Measure - Alzheimer's Disease Assessment Scale - Cognitive Subscale (Rosen et al., 1984).
Change from Baseline in the elderly participant's Quality of Life
Outcome Measure - Quality of Life in Alzheimer's Disease (Logsdon et al., 2002).
Change from Baseline in the caregiver's overall health
Outcome Measure - Short Form-12 Health Survey (Ware et al., 1996).

Secondary Outcome Measures

Change from Baseline in the elderly participant's Neuropsychiatric Symptoms
Outcome Measure - The Neuropsychiatric Inventory Questionnaire(Cummings et al.,1994)
Change from Baseline in the elderly participant's Functional Capacity
Outcome Measure - Barthel Index of Activities of Daily Living (Mahoney & Barthel, 1965)
Change from Baseline in the elderly participant's Depressive Symptoms
Outcome Measure - Geriatric Depression Scale - 15 items (Sheikh & Yesavage,1986)
Change from Baseline in the dyad's (elderly participant and caregiver) Quality of the Relationship
Outcome Measure - Quality of the carer-patient relationship (Spruytte, 2002)

Full Information

First Posted
April 20, 2018
Last Updated
May 2, 2018
Sponsor
Escola Superior de Enfermagem de Coimbra
Collaborators
Grouping of Health Centers of Greater Porto I - Santo Tirso/Trofa, Group of Health Centers of Greater Porto IV - Póvoa de Varzim/Vila do Conde
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1. Study Identification

Unique Protocol Identification Number
NCT03514095
Brief Title
Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty
Acronym
ECOG_CS
Official Title
Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Enfermagem de Coimbra
Collaborators
Grouping of Health Centers of Greater Porto I - Santo Tirso/Trofa, Group of Health Centers of Greater Porto IV - Póvoa de Varzim/Vila do Conde

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cognitive Stimulation (CS) in the elderly, as a group intervention, shows benefits on the cognition and quality of life of people with neurocognitive disorder (NCD)(ie, dementia). The evidence of cognitive stimulation as an individualized intervention, conducted at home, by the caregiver is limited. The main objective of this trial is to evaluate the effectiveness of the Individual Cognitive Stimulation Therapy program - "Making a Difference 3 - individual Cognitive Stimulation Therapy (MD3), its acceptability and applicability by the dyad (people with NCD and their caregiver) in the Portuguese population. To achieve this purpose a pilot study will be conducted (randomized control trial), with two moments of evaluation - before the intervention of individual cognitive stimulation and after the intervention in both groups (Group 1 - group subject to intervention: individual cognitive stimulation program called "MD3"; Group 2 - group subject to usual care).The investigators intend to know the effect of the program on cognitive domains, quality of life and relationship between caregiver and care recipient. And, as well as understand the acceptability and applicability of the program by participants (dyad).
Detailed Description
Caring for people with mild and major neurocognitive disorder (NCD) is a major challenge for the current international health care systems. People with NCD lack care to meet their needs, which makes the development and implementation of specific interventions a priority. These should aim to increase the self-care potential of people with mild and major NCD, by promoting their autonomy and family support. "Making a Difference 3 (MD3) - Individual Cognitive Stimulation Therapy: A manual for carers" is an example of an individual cognitive stimulation program. This program is useful for a large number of elderly people who, for various reasons, can not participate in group cognitive stimulation program. This individual cognitive stimulation can be developed in several settings, including in people's homes and with use of inexpensive resources, but very little knowledge has been produced in this area. Studies carried out in the family environment and involving the caregiver showed gains for the people, such as improvement in cognitive performance including memory, verbal fluency, problem solving capacity, less institutionalization; and for their caregivers, improvement in their overall well-being including decreased feelings of hostility. However, the methodological fragility of these studies is emphasized in both the design, sample size and lack of uniformity in the type and time of the intervention. The individual cognitive stimulation that we intend to study by applying the MD3 program is considered a complex intervention because it followed in its construction the guidelines recommended by the Medical Research Council. The efficacy study of this individual cognitive stimulation program, developed at the National Health Service (NHS) in England, and which we intend to replicate in part, was a 25-week randomized controlled trial of 273 dyads. In this study, there were no statistically significant differences between the experimental group and the control group in the outcomes evaluated as: cognition, self-report quality of life, psychological and behavioral symptomatology, and depressive symptomatology. Regarding the caregivers, the study revealed that there were no statistically significant differences in mental and physical health between groups, but the intervention group revealed a higher quality of life. However, some conditioning factors that may have compromised the final results of this study, namely the loss of participants and the low adherence to the program (22% of the participants did not complete any of the sessions and only 51% of the dyads completed more than 30 sessions). Dyads that completed more sessions showed improvement in the quality of the relationship, while the caregivers showed less depressive symptoms. The investigators understand that, in the context of these results, more studies are needed to evaluate the effects of this program, but mainly it is necessary to find strategies that limit the low adherence and understand the applicability of the MD3 program. In summary, there is no evidence base on the efficacy of individual cognitive stimulation in people with mild or major NCD in the home setting of the elderly, managed by the informal caregiver and supervised by health professionals (eg nurses). In addition, in Portugal, there are still no structured programs of cognitive stimulation with individual sessions for use in the home context. In this sense, the team of the present project proposes to produce national evidence on the efficacy of individual cognitive stimulation in people with mild and major NCD in the elderly domiciliary context, managed by the informal caregiver and supervised by health professionals. Simultaneously, to know the acceptability (by the adhesion - number of stimulation sessions performed - by the dyad) and the practicability of the program (evaluate to what extent the sessions are practical and practicable within the home context.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurocognitive Disorders, Dementia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned in two groups, a control group who will usual care by their caregivers and an experimental group who will receive the MD3 program.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The randomization process it will be done in https://www.random.org/ by an independent person.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group shall participate in the usual home-based care provided by their carer.
Arm Title
Individual Cognitive Stimulation Therapy
Arm Type
Experimental
Arm Description
The experimental group shall participate in the Making a Difference 3 program (Yates et al., 2015) is aimed at elderly people with mild or major neurocognitive disorder, where informal caregiver (family, friend or neighbour) assume a partnering role in an one-to-one approach. The program is composed by a range of stimulating activities (sessions), each with two levels of difficulty. The carers are introduced to a set of key principles that guides them during individual cognitive stimulation sessions, tailoring the interventions to the needs and reality of the elderly participants.
Intervention Type
Other
Intervention Name(s)
Individual Cognitive Stimulation Therapy Program
Intervention Description
This program unfolds in 3 weekly sessions of 30 minutes, for 12 weeks, thus completing a total of 36 sessions. Over the 3 months, the dyad will need to be monitored for orientation / monitoring of intervention by an element of the research team. This monitoring will be bi-weekly, in person or by phone - here according to the choice of the dyad). After each session the caregiver has a questionnaire to complete (intervention monitoring strategy), with the objective of evaluating the acceptability and applicability of the program.
Primary Outcome Measure Information:
Title
Change from Baseline in the elderly participant's Cognition
Description
Outcome Measure - Alzheimer's Disease Assessment Scale - Cognitive Subscale (Rosen et al., 1984).
Time Frame
Post-intervention assessment (week 13)
Title
Change from Baseline in the elderly participant's Quality of Life
Description
Outcome Measure - Quality of Life in Alzheimer's Disease (Logsdon et al., 2002).
Time Frame
Post-intervention assessment (week 13)
Title
Change from Baseline in the caregiver's overall health
Description
Outcome Measure - Short Form-12 Health Survey (Ware et al., 1996).
Time Frame
Post-intervention assessment (week 13)
Secondary Outcome Measure Information:
Title
Change from Baseline in the elderly participant's Neuropsychiatric Symptoms
Description
Outcome Measure - The Neuropsychiatric Inventory Questionnaire(Cummings et al.,1994)
Time Frame
Post-intervention assessment (week 13)
Title
Change from Baseline in the elderly participant's Functional Capacity
Description
Outcome Measure - Barthel Index of Activities of Daily Living (Mahoney & Barthel, 1965)
Time Frame
Post-intervention assessment (week 13)
Title
Change from Baseline in the elderly participant's Depressive Symptoms
Description
Outcome Measure - Geriatric Depression Scale - 15 items (Sheikh & Yesavage,1986)
Time Frame
Post-intervention assessment (week 13)
Title
Change from Baseline in the dyad's (elderly participant and caregiver) Quality of the Relationship
Description
Outcome Measure - Quality of the carer-patient relationship (Spruytte, 2002)
Time Frame
Post-intervention assessment (week 13)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elderly person with 60 years of age or older; Diagnosis of mild or major neurocognitive disorder, performed by a physician specialized in neurology or psychiatry, or who is validated by the family physician in accordance with DSMIII/IV/5 or ICD-9/10 criteria; Presence of mild to moderate cognitive impairment according to the 6-Item Cognitive Decline Test (6CIT); Capable of communicating and understanding communication; Without a physical illness or significant disability (eg elderly people who are on dialysis or bedridden); Living in the community (in their home); Have an informal caregiver available and able to develop the individual cognitive stimulation program. Exclusion Criteria: Elderly / informal caregiver with a history of severe psychiatric illness diagnosed before 60 years of age; Informal caregiver with cognitive impairment, even if mild (mild PNC according to DSM-5 criteria); Elderly people who do not live in their home.
Facility Information:
Facility Name
Health Sciences Research Unit: Nursing
City
Coimbra
ZIP/Postal Code
3000-232
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10556864
Citation
Brooke P, Bullock R. Validation of a 6 item cognitive impairment test with a view to primary care usage. Int J Geriatr Psychiatry. 1999 Nov;14(11):936-40.
Results Reference
background
Citation
Yates, L.; Orrel M., Phoung, L.; Spector, O.; Woods, B.; Orgeta V. Making a Difference 3 - Individual Cognitive Stimulation Therapy: A manual for carers. London: The Journal of Dementia Care : Hawker Publications; 2015. 160 p.
Results Reference
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PubMed Identifier
12396755
Citation
Spruytte N, Van Audenhove C, Lammertyn F, Storms G. The quality of the caregiving relationship in informal care for older adults with dementia and chronic psychiatric patients. Psychol Psychother. 2002 Sep;75(Pt 3):295-311. doi: 10.1348/147608302320365208.
Results Reference
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Citation
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Citation
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Results Reference
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Citation
Quayhagen, M. & Quayhagen, M. (2001). Testing of a cognitive stimulation intervention for dementia caregiving dyads. Neuropsychological Rehabilitation, 11(3), 319-332. http://doi.org/10.1080/09602010042000024
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Results Reference
derived

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Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty

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