Cognitive DeclineNCT03370796
Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context
A study testing Reminiscence Therapy Program in people with Cognitive Decline and Dementia, run by Escola Superior de Enfermagem de Coimbra at 1 site in Portugal.
Trial summary
The project presented here respond to this emerging need by implementing a Reminiscence Therapy program dedicated to elderly people in an institutional context. This will be a multicenter, randomized controlled study in which the participants' allocation will be made without their knowledge. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Decline, Dementia, Cognitive Impairment
- What is being tested?
- Reminiscence Therapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2017to 31 Jul 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- have the capacity to informally consent participation in the study;
- have the ability to remain in a group within 60 minutes;
- have sufficient auditory capacity to participate in discussions;
- have sufficient visual capacity to see the materials that are part of the applied program;
- have criteria of cognitive decline.
Who cannot join
- present an unstable clinical condition;
- do not wish to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The project presented here respond to this emerging need by implementing a Reminiscence Therapy program dedicated to elderly people in an institutional context. This will be a multicenter, randomized controlled study in which the participants' allocation will be made without their knowledge. Before the randomization process, the screening evaluation will be done, which will allow to verify the presence of the inclusion and exclusion criteria. The target population will be people age 65 or above years who present cognitive decline. After the randomization process, participants will be allocated randomly in the experimental group where the reminiscence program (composed by a main strand and maintenance strand) or in the usual institutional care group. The evaluation of the participants will be carried out individually and will take place in four different moments.This study will be conducted in RSE in the central region of Portugal.
Read the detailed description
There are an estimated 46 million people with major Neurocognitive Disorders, and this figure is expected to increase to double every 20 years, with about 131.5 million people diagnosed by 2050 (Prince et al., 2015). The economic impact is significant, with costs estimated at US $ 818 million (Prince et al., 2015). In 2018, this value is expected to reach the trillion US dollar level, with serious implications for global societies and government authorities (Prince et al., 2015). Elderly people with cognitive decline progressively lose their cognitive capacities and experience motor disorders, leading, in more advanced stages of the disease, to family and carer burden, which often culminate in their institutionalization.
According to Kuske et al. (2009), about 60% of all institutionalized people in industrialized countries present some form of dementia, which poses new challenges for these institutions and for its professionals. This process is inevitably associated with an increase in the prevalence of chronic degenerative diseases, particularly neurocognitive disorders (NCD). The category of NCD includes all the disorders in which the primary clinical deficit is in cognitive function, being this deficit acquired (documented by standardized neurological tests or by quantitative clinical evaluation), that is, it represents a decline from a previous functional level (APA, 2013).
In this sequential line, priority is given to the design of interventions that effectively focus on the stimulation of best practices for active aging, aiming at the implementation of measures that minimize the impact of NCD by slowing down their progression or modulating their associated symptomatology (Directorate General for Health, 2016). Knowing that the drugs introduced so far in clinical practice are restricted to symptomatic control, not being able to prevent the progression of the disease, non-pharmacological interventions have been gaining special prominence. The literature emphasizes the value of Reminiscence as a strategy for people with cognitive deficits. This stimulating intervention is based on the recovery of significant life events with special focus on resolving past conflicts.
Reminiscence is a pleasant and stimulating activity that contributes to the reduction of social isolation, revealing itself as a strategy to promote interpersonal relations (Cooney et al., 2014; Gibson, 2004). It has been reported as an intervention associated with pleasure, safety and sense of belonging (Cappeliez \& O'Rourke, 2006). It is also a low-cost therapeutic option (Siverová \& Bužgová, 2014). In addition, according to Westerhof, Bohlmeijer and Webster (2010), the exchange of autobiographical memories through Reminiscence, even in the final stages of the dementia, can produce considerable and measurable gains that are reflected in increased levels of well-being, decreased depression levels and improved cognitive function as well as increased verbal fluency.
In view of the above, it is considered that the implementation of a structured Reminiscence program can maximize cognitive functioning, improve depressive symptoms and promote quality of life by facilitating the adaptation process and contributing to the promotion of the dignity of people with cognitive decline and who are in Day Care regime or living in Residential Structures for the Elderly (RSE).
- Conditions
- Cognitive Decline, Dementia, Cognitive Impairment
- Being tested
- Reminiscence Therapy Program
- Keywords
- dementia, cognitive impairment, cognition, quality of life, depressive symptoms, Reminiscence Therapy
- Medical subject headings
- Cognitive Dysfunction, Dementia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminiscence Therapy ProgramOther
The Reminiscence Therapy program is composed of: (i) main strand lasting 7 weeks, with sessions twice a week (total of 14 sessions); (ii) maintenance strand, which runs for 7 weeks, once a week (total of 7 sessions). The duration for each session will be 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Reminiscence Therapy | Experimental | The Reminiscence program will consist of a set of sessions thematically sequenced topics that address the life course of the participant. Each session will integrate a group of activities that will be developed in group and will have a didactic character, privileging subjective interests and interpersonal communication. Receives: Other: Reminiscence Therapy Program |
| Control Group | No intervention | The control group shall participate in the institutional care provided by the professionals of each RSE. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the participant's Cognition
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Measured: Intermediate assessment (week 7)
Change from Baseline in the participant's Cognition
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Measured: Post-intervention assessment (week 14)
Change from Baseline in the participant's Cognition
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Measured: Five-week follow-up assessment (week 19)
Change from Baseline in the participant's Depressive Symptoms
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Measured: Intermediate assessment (week 7)
Change from Baseline in the participant's Depressive Symptoms
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Measured: Post-intervention assessment (week 14)
Change from Baseline in the participant's Depressive Symptoms
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Measured: Five-week follow-up assessment (week 19)
Change from Baseline in the participant's Quality of Life
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Measured: Intermediate assessment (week 7)
Change from Baseline in the participant's Quality of Life
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Measured: Post-intervention assessment (week 14)
Change from Baseline in the participant's Quality of Life
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Measured: Five-week follow-up assessment (week 19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start1 Sep 2017
- Primary completion31 Jul 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Enfermagem de Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- The Health Sciences Research Unit: Nursing
- Responsible party
- Principal investigator, Joao Apostolo, Escola Superior de Enfermagem de Coimbra
- Investigators
- João LA Apóstolo, PhD, Principal investigator, Nursing School of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370796
- Sponsor's protocol ID
- ECOG_REM
- Status last verified
- May 2018
- First submitted
- 30 Nov 2017
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kuske B, Luck T, Hanns S, Matschinger H, Angermeyer MC, Behrens J, Riedel-Heller SG. Training in dementia care: a cluster-randomized controlled trial of a training program for nursing home staff in Germany. Int Psychogeriatr. 2009 Apr;21(2):295-308. doi: 10.1017/S1041610208008387. Epub 2009 Feb 5.
PubMed 19193252Directorate-General for Health. (2016). Portugal Saúde Mental em Números - 2015. Programa Nacional para a Saúde Mental. 75-86. Retrieved from http://www.apah.pt/media/publicacoes_tecnicas_sector_saude_2/Saude_Mental.pdf
APA (213). Diagnostic and statistical manual of mental disorders (5th ed).(American Psychiatric Association, Ed.). Arlington.
Cooney A, Hunter A, Murphy K, Casey D, Devane D, Smyth S, Dempsey L, Murphy E, Jordan F, O'Shea E. 'Seeing me through my memories': a grounded theory study on using reminiscence with people with dementia living in long-term care. J Clin Nurs. 2014 Dec;23(23-24):3564-74. doi: 10.1111/jocn.12645. Epub 2014 Jul 12.
PubMed 25040857Gibson, F. (2004). The past in the present: Using reminisce in health and social care. Baltimore: Health Professions Press.
Cappeliez P, O'Rourke N. Empirical validation of a model of reminiscence and health in later life. J Gerontol B Psychol Sci Soc Sci. 2006 Jul;61(4):P237-44. doi: 10.1093/geronb/61.4.p237.
PubMed 16855036Siverová, J., & Bužgová, R. (2014). Influence Reminiscence Therapy on Quality of Life Patients in the Long-Term Hospital. Central European Journal of Nursing and Midwifery, 5 (1), 21-28
Westerhof, G. J., Bohlmeijer, E., & Webster, J. D. (2010). Reminiscence and mental health: A review of recent progress in theory, research and interventions. Ageing and Society, 30 (04), 697-721.
Prince, M., Wimo, A., Guerchet, M., Ali, G., Wu, Y., & Prina, M. (2015). World Alzheimer Report 2015 The Global Impact of Dementia. Alzheimer's Disease International. Retrieved from https://www.alz.co.uk/research/WorldAlzheimerReport2015.pdf
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context
- ClinicalTrials.gov ID
- NCT03370796
- Acronym / sponsor ID
- ECOG_REM
- Conditions
- Cognitive Decline, Dementia, Cognitive Impairment
- Keywords
- dementia, cognitive impairment, cognition, quality of life, depressive symptoms, Reminiscence Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Escola Superior de Enfermagem de CoimbraUniversity, hospital or other
- Collaborators
- The Health Sciences Research Unit: Nursing
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jul 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 12 Dec 2017 (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.
The project presented here respond to this emerging need by implementing a Reminiscence Therapy program dedicated to elderly people in an institutional context. This will be a multicenter, randomized controlled study in which the participants' allocation will be made without their knowledge. Before the randomization process, the screening evaluation will be done, which will allow to verify the presence of the inclusion and exclusion criteria. The target population will be people age 65 or above years who present cognitive decline. After the randomization process, participants will be allocated randomly in the experimental group where the reminiscence program (composed by a main strand and maintenance strand) or in the usual institutional care group. The evaluation of the participants will be carried out individually and will take place in four different moments.This study will be conducted in RSE in the central region of Portugal.
Detailed description
There are an estimated 46 million people with major Neurocognitive Disorders, and this figure is expected to increase to double every 20 years, with about 131.5 million people diagnosed by 2050 (Prince et al., 2015). The economic impact is significant, with costs estimated at US $ 818 million (Prince et al., 2015). In 2018, this value is expected to reach the trillion US dollar level, with serious implications for global societies and government authorities (Prince et al., 2015). Elderly people with cognitive decline progressively lose their cognitive capacities and experience motor disorders, leading, in more advanced stages of the disease, to family and carer burden, which often culminate in their institutionalization.
According to Kuske et al. (2009), about 60% of all institutionalized people in industrialized countries present some form of dementia, which poses new challenges for these institutions and for its professionals. This process is inevitably associated with an increase in the prevalence of chronic degenerative diseases, particularly neurocognitive disorders (NCD). The category of NCD includes all the disorders in which the primary clinical deficit is in cognitive function, being this deficit acquired (documented by standardized neurological tests or by quantitative clinical evaluation), that is, it represents a decline from a previous functional level (APA, 2013).
In this sequential line, priority is given to the design of interventions that effectively focus on the stimulation of best practices for active aging, aiming at the implementation of measures that minimize the impact of NCD by slowing down their progression or modulating their associated symptomatology (Directorate General for Health, 2016). Knowing that the drugs introduced so far in clinical practice are restricted to symptomatic control, not being able to prevent the progression of the disease, non-pharmacological interventions have been gaining special prominence. The literature emphasizes the value of Reminiscence as a strategy for people with cognitive deficits. This stimulating intervention is based on the recovery of significant life events with special focus on resolving past conflicts.
Reminiscence is a pleasant and stimulating activity that contributes to the reduction of social isolation, revealing itself as a strategy to promote interpersonal relations (Cooney et al., 2014; Gibson, 2004). It has been reported as an intervention associated with pleasure, safety and sense of belonging (Cappeliez \& O'Rourke, 2006). It is also a low-cost therapeutic option (Siverová \& Bužgová, 2014). In addition, according to Westerhof, Bohlmeijer and Webster (2010), the exchange of autobiographical memories through Reminiscence, even in the final stages of the dementia, can produce considerable and measurable gains that are reflected in increased levels of well-being, decreased depression levels and improved cognitive function as well as increased verbal fluency.
In view of the above, it is considered that the implementation of a structured Reminiscence program can maximize cognitive functioning, improve depressive symptoms and promote quality of life by facilitating the adaptation process and contributing to the promotion of the dignity of people with cognitive decline and who are in Day Care regime or living in Residential Structures for the Elderly (RSE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reminiscence Therapy | Experimental | Other: Reminiscence Therapy ProgramThe Reminiscence program will consist of a set of sessions thematically sequenced topics that address the life course of the participant. Each session will integrate a group of activities that will be developed in group and will have a didactic character, privileging subjective interests and interpersonal communication. |
| Control Group | No intervention | –The control group shall participate in the institutional care provided by the professionals of each RSE. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- have the capacity to informally consent participation in the study;
- have the ability to remain in a group within 60 minutes;
- have sufficient auditory capacity to participate in discussions;
- have sufficient visual capacity to see the materials that are part of the applied program;
- have criteria of cognitive decline.
Key exclusion criteria (2 listed)
- present an unstable clinical condition;
- do not wish to participate in the study.
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 |
|---|---|---|
| Reminiscence Therapy ProgramThe Reminiscence Therapy program is composed of: (i) main strand lasting 7 weeks, with sessions twice a week (total of 14 sessions); (ii) maintenance strand, which runs for 7 weeks, once a week (total of 7 sessions). The duration for each session will be 60 minutes. | Other | Reminiscence Therapy |
Primary outcome
Change from Baseline in the participant's Cognition
Time frame: Intermediate assessment (week 7)
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Change from Baseline in the participant's Cognition
Time frame: Post-intervention assessment (week 14)
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Change from Baseline in the participant's Cognition
Time frame: Five-week follow-up assessment (week 19)
Outcome Measure - Montreal Cognitive Assessment (MoCA)
Change from Baseline in the participant's Depressive Symptoms
Time frame: Intermediate assessment (week 7)
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Change from Baseline in the participant's Depressive Symptoms
Time frame: Post-intervention assessment (week 14)
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Change from Baseline in the participant's Depressive Symptoms
Time frame: Five-week follow-up assessment (week 19)
Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)
Change from Baseline in the participant's Quality of Life
Time frame: Intermediate assessment (week 7)
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Change from Baseline in the participant's Quality of Life
Time frame: Post-intervention assessment (week 14)
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Change from Baseline in the participant's Quality of Life
Time frame: Five-week follow-up assessment (week 19)
Outcome Measure -World Health Organization Quality of Life-Older Adults Module (WHOQOL-OLD)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 19193252Kuske B, Luck T, Hanns S, Matschinger H, Angermeyer MC, Behrens J, Riedel-Heller SG. Training in dementia care: a cluster-randomized controlled trial of a training program for nursing home staff in Germany. Int Psychogeriatr. 2009 Apr;21(2):295-308. doi: 10.1017/S1041610208008387. Epub 2009 Feb 5.
- BackgroundDirectorate-General for Health. (2016). Portugal Saúde Mental em Números - 2015. Programa Nacional para a Saúde Mental. 75-86. Retrieved from http://www.apah.pt/media/publicacoes_tecnicas_sector_saude_2/Saude_Mental.pdf
- BackgroundAPA (213). Diagnostic and statistical manual of mental disorders (5th ed).(American Psychiatric Association, Ed.). Arlington.
- Background: PubMed 25040857Cooney A, Hunter A, Murphy K, Casey D, Devane D, Smyth S, Dempsey L, Murphy E, Jordan F, O'Shea E. 'Seeing me through my memories': a grounded theory study on using reminiscence with people with dementia living in long-term care. J Clin Nurs. 2014 Dec;23(23-24):3564-74. doi: 10.1111/jocn.12645. Epub 2014 Jul 12.
- BackgroundGibson, F. (2004). The past in the present: Using reminisce in health and social care. Baltimore: Health Professions Press.
- Background: PubMed 16855036Cappeliez P, O'Rourke N. Empirical validation of a model of reminiscence and health in later life. J Gerontol B Psychol Sci Soc Sci. 2006 Jul;61(4):P237-44. doi: 10.1093/geronb/61.4.p237.
- BackgroundSiverová, J., & Bužgová, R. (2014). Influence Reminiscence Therapy on Quality of Life Patients in the Long-Term Hospital. Central European Journal of Nursing and Midwifery, 5 (1), 21-28
- BackgroundWesterhof, G. J., Bohlmeijer, E., & Webster, J. D. (2010). Reminiscence and mental health: A review of recent progress in theory, research and interventions. Ageing and Society, 30 (04), 697-721.
- BackgroundPrince, M., Wimo, A., Guerchet, M., Ali, G., Wu, Y., & Prina, M. (2015). World Alzheimer Report 2015 The Global Impact of Dementia. Alzheimer's Disease International. Retrieved from https://www.alz.co.uk/research/WorldAlzheimerReport2015.pdf
- Individual participant dataSharing planned: Undecided
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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.
João LA Apóstolo, PhD principal investigator
Nursing School of Coimbra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminiscence Therapy Program in people with Cognitive Decline 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 5 inclusion and 2 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 11 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 participant's Cognition (time frame: Intermediate assessment (week 7)). The study lists 9 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 NCT03370796, which also lists 9 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 11 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.