Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty

Dementia Clinical Trial

— ECOG_CS  

Official title:

Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03514095
• Other study ID #: ECOG_CS
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: May 2018
• Source: Escola Superior de Enfermagem de Coimbra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Neurocognitive Disorders

Intervention

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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Escola Superior de Enfermagem de Coimbra	ACES Grande Porto I - Santo Tirso/Trofa, ACES Grande Porto IV - Póvoa de Varzim/Vila do Conde

Country where clinical trial is conducted

Portugal, 

References & Publications (13)

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. — View Citation

Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. — View Citation

Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. — View Citation

MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. — View Citation

Orgeta V, Leung P, Yates L, Kang S, Hoare Z, Henderson C, Whitaker C, Burns A, Knapp M, Leroi I, Moniz-Cook ED, Pearson S, Simpson S, Spector A, Roberts S, Russell IT, de Waal H, Woods RT, Orrell M. Individual cognitive stimulation therapy for dementia: a clinical effectiveness and cost-effectiveness pragmatic, multicentre, randomised controlled trial. Health Technol Assess. 2015 Aug;19(64):1-108. doi: 10.3310/hta19640. — View Citation

Orrell M, Yates LA, Burns A, Russell I, Woods RT, Hoare Z, Moniz-Cook E, Henderson C, Knapp M, Spector A, Orgeta V. Individual Cognitive Stimulation Therapy for dementia (iCST): study protocol for a randomized controlled trial. Trials. 2012 Sep 22;13:172. doi: 10.1186/1745-6215-13-172. — View Citation

Quayhagen MP, Quayhagen M, Corbeil RR, Hendrix RC, Jackson JE, Snyder L, Bower D. Coping with dementia: evaluation of four nonpharmacologic interventions. Int Psychogeriatr. 2000 Jun;12(2):249-65. — View 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

Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. — View Citation

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

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. — View Citation

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. — View 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.

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the elderly participant's Cognition	Outcome Measure - Alzheimer's Disease Assessment Scale - Cognitive Subscale (Rosen et al., 1984).	Post-intervention assessment (week 13)
Primary	Change from Baseline in the elderly participant's Quality of Life	Outcome Measure - Quality of Life in Alzheimer's Disease (Logsdon et al., 2002).	Post-intervention assessment (week 13)
Primary	Change from Baseline in the caregiver's overall health	Outcome Measure - Short Form-12 Health Survey (Ware et al., 1996).	Post-intervention assessment (week 13)
Secondary	Change from Baseline in the elderly participant's Neuropsychiatric Symptoms	Outcome Measure - The Neuropsychiatric Inventory Questionnaire(Cummings et al.,1994)	Post-intervention assessment (week 13)
Secondary	Change from Baseline in the elderly participant's Functional Capacity	Outcome Measure - Barthel Index of Activities of Daily Living (Mahoney & Barthel, 1965)	Post-intervention assessment (week 13)
Secondary	Change from Baseline in the elderly participant's Depressive Symptoms	Outcome Measure - Geriatric Depression Scale - 15 items (Sheikh & Yesavage,1986)	Post-intervention assessment (week 13)
Secondary	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)	Post-intervention assessment (week 13)