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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514095
Recruitment Status : Active, not recruiting
First Posted : May 2, 2018
Last Update Posted : May 7, 2018
Sponsor:
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
Information provided by (Responsible Party):
Joao Apostolo, Escola Superior de Enfermagem de Coimbra

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).

Condition or disease Intervention/treatment Phase
Neurocognitive Disorders Dementia Other: Individual Cognitive Stimulation Therapy Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The randomization process it will be done in https://www.random.org/ by an independent person.
Primary Purpose: Other
Official Title: Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
No Intervention: Control Group
The control group shall participate in the usual home-based care provided by their carer.
Experimental: Individual Cognitive Stimulation Therapy
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.
Other: Individual Cognitive Stimulation Therapy Program

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 Measures :
  1. Change from Baseline in the elderly participant's Cognition [ Time Frame: Post-intervention assessment (week 13) ]
    Outcome Measure - Alzheimer's Disease Assessment Scale - Cognitive Subscale (Rosen et al., 1984).

  2. Change from Baseline in the elderly participant's Quality of Life [ Time Frame: Post-intervention assessment (week 13) ]
    Outcome Measure - Quality of Life in Alzheimer's Disease (Logsdon et al., 2002).

  3. Change from Baseline in the caregiver's overall health [ Time Frame: Post-intervention assessment (week 13) ]
    Outcome Measure - Short Form-12 Health Survey (Ware et al., 1996).


Secondary Outcome Measures :
  1. Change from Baseline in the elderly participant's Neuropsychiatric Symptoms [ Time Frame: Post-intervention assessment (week 13) ]
    Outcome Measure - The Neuropsychiatric Inventory Questionnaire(Cummings et al.,1994)

  2. Change from Baseline in the elderly participant's Functional Capacity [ Time Frame: Post-intervention assessment (week 13) ]
    Outcome Measure - Barthel Index of Activities of Daily Living (Mahoney & Barthel, 1965)

  3. Change from Baseline in the elderly participant's Depressive Symptoms [ Time Frame: Post-intervention assessment (week 13) ]
    Outcome Measure - Geriatric Depression Scale - 15 items (Sheikh & Yesavage,1986)

  4. Change from Baseline in the dyad's (elderly participant and caregiver) Quality of the Relationship [ Time Frame: Post-intervention assessment (week 13) ]
    Outcome Measure - Quality of the carer-patient relationship (Spruytte, 2002)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514095


Locations
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Portugal
Health Sciences Research Unit: Nursing
Coimbra, Portugal, 3000-232
Sponsors and Collaborators
Escola Superior de Enfermagem de Coimbra
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

Publications:
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.
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
Sheikh, J. I., & Yesavage, J. A. (1986). Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. Clinical Gerontologist, 5, 165-173.

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Responsible Party: Joao Apostolo, Ph.D, Coordinator Professo, Escola Superior de Enfermagem de Coimbra
ClinicalTrials.gov Identifier: NCT03514095    
Other Study ID Numbers: ECOG_CS
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Neurocognitive Disorders
Mental Disorders
Pathologic Processes