Neurocognitive DisordersECOG_CSNCT03514095
Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty
A study testing Individual Cognitive Stimulation Therapy Program in people with Neurocognitive Disorders and Dementia, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neurocognitive Disorders, Dementia
- What is being tested?
- Individual Cognitive Stimulation Therapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Neurocognitive Disorders, Dementia
- Being tested
- Individual Cognitive Stimulation Therapy Program
- Medical subject headings
- Neurocognitive Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Cognitive Stimulation Therapy ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Individual Cognitive Stimulation Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the elderly participant's Cognition
Outcome Measure - Alzheimer's Disease Assessment Scale - Cognitive Subscale (Rosen et al., 1984).
Measured: 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).
Measured: 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).
Measured: Post-intervention assessment (week 13)
Secondary outcomes (4)
Change from Baseline in the elderly participant's Neuropsychiatric Symptoms
Outcome Measure - The Neuropsychiatric Inventory Questionnaire(Cummings et al.,1994)
Measured: Post-intervention assessment (week 13)
Change from Baseline in the elderly participant's Functional Capacity
Outcome Measure - Barthel Index of Activities of Daily Living (Mahoney \& Barthel, 1965)
Measured: Post-intervention assessment (week 13)
Change from Baseline in the elderly participant's Depressive Symptoms
Outcome Measure - Geriatric Depression Scale - 15 items (Sheikh \& Yesavage,1986)
Measured: Post-intervention assessment (week 13)
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)
Measured: Post-intervention assessment (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start1 May 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Enfermagem de Coimbra
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Joao Apostolo, Escola Superior de Enfermagem de Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514095
- Sponsor's protocol ID
- ECOG_CS
- Acronym
- ECOG_CS
- Status last verified
- May 2018
- First submitted
- 20 Apr 2018
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10556864Yates, 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.
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.
PubMed 12396755Orgeta 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.
PubMed 26292178Orrell 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.
PubMed 22998983Quayhagen, 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
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.
PubMed 10937544Rosen 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.
PubMed 6496779Logsdon 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.
PubMed 12021425Ware 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.
PubMed 8628042Cummings 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.
PubMed 7991117MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Sheikh, J. I., & Yesavage, J. A. (1986). Geriatric Depression Scale (GDS): Recent evidence and development of a shorter version. Clinical Gerontologist, 5, 165-173.
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.
PubMed 34880809
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Stimulation in the Elderly: Individual Intervention on Cognitive Frailty
- ClinicalTrials.gov ID
- NCT03514095
- Acronym / sponsor ID
- ECOG_CS / ECOG_CS
- Conditions
- Neurocognitive Disorders, Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Escola Superior de Enfermagem de CoimbraUniversity, hospital or other
- 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
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group shall participate in the usual home-based care provided by their carer. |
| Individual Cognitive Stimulation Therapy | Experimental | Other: Individual Cognitive Stimulation Therapy ProgramThe 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Cognitive Stimulation Therapy ProgramThis 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. | Other | Individual Cognitive Stimulation Therapy |
Primary outcome
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).
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).
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).
4 secondary outcomes
Change from Baseline in the elderly participant's Neuropsychiatric Symptoms
Time frame: Post-intervention assessment (week 13)
Change from Baseline in the elderly participant's Functional Capacity
Time frame: Post-intervention assessment (week 13)
Change from Baseline in the elderly participant's Depressive Symptoms
Time frame: Post-intervention assessment (week 13)
Change from Baseline in the dyad's (elderly participant and caregiver) Quality of the Relationship
Time frame: Post-intervention assessment (week 13)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Background: PubMed 10556864Brooke 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.
- BackgroundYates, 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: PubMed 12396755Spruytte 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.
- Background: PubMed 26292178Orgeta 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.
- Background: PubMed 22998983Orrell 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.
- BackgroundQuayhagen, 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: PubMed 10937544Quayhagen 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.
- Background: PubMed 6496779Rosen 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.
- Background: PubMed 12021425Logsdon 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.
- Background: PubMed 8628042Ware 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.
- Background: PubMed 7991117Cummings 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.
- Background: PubMed 14258950MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Neurocognitive Disorders
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Cognitive Stimulation Therapy Program in people with Neurocognitive Disorders and Dementia, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the elderly participant's Cognition (time frame: Post-intervention assessment (week 13)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03514095, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.