Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty

NCT03514095 | Unknown

• 1 other identifier: ECOG_CS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Neurocognitive Disorders; Dementia

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (4)

• Change from Baseline in the elderly participant's Neuropsychiatric Symptoms

  Post-intervention assessment (week 13)

• Change from Baseline in the elderly participant's Functional Capacity

  Post-intervention assessment (week 13)

• Change from Baseline in the elderly participant's Depressive Symptoms

  Post-intervention assessment (week 13)

• Change from Baseline in the dyad's (elderly participant and caregiver) Quality of the Relationship

  Post-intervention assessment (week 13)

Study Arms (2)

Control Group

NO INTERVENTION

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

Individual Cognitive Stimulation Therapy

EXPERIMENTAL

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

Interventions

Individual Cognitive Stimulation Therapy Program OTHER

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.

Individual Cognitive Stimulation Therapy

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Enfermagem de Coimbra: lead
• Grouping of Health Centers of Greater Porto I - Santo Tirso/Trofa: collaborator
• Group of Health Centers of Greater Porto IV - Póvoa de Varzim/Vila do Conde: collaborator

Study Sites (1)

Health Sciences Research Unit: Nursing

Coimbra, 3000-232, Portugal

Location

Related Publications (14)

• 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.

  PMID: 10556864 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 12396755 BACKGROUND

• 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.

  PMID: 26292178 BACKGROUND

• 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.

  PMID: 22998983 BACKGROUND

• 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

  BACKGROUND

• 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. doi: 10.1017/s1041610200006360.

  PMID: 10937544 BACKGROUND

• Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.

  PMID: 6496779 BACKGROUND

• 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. doi: 10.1097/00006842-200205000-00016.

  PMID: 12021425 BACKGROUND

• 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. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• 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. doi: 10.1212/wnl.44.12.2308.

  PMID: 7991117 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

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

  BACKGROUND

• Silva R, Bobrowicz-Campos E, Santos-Costa P, Cruz AR, Apostolo J. A Home-Based Individual Cognitive Stimulation Program for Older Adults With Cognitive Impairment: A Randomized Controlled Trial. Front Psychol. 2021 Nov 22;12:741955. doi: 10.3389/fpsyg.2021.741955. eCollection 2021.

  PMID: 34880809 DERIVED

MeSH Terms

Conditions

Neurocognitive Disorders; Dementia

Condition Hierarchy (Ancestors)

Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization process it will be done in https://www.random.org/ by an independent person.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, Coordinator Professo

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: May 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: May 7, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)