NCT03370796

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

11 months

First QC Date

November 30, 2017

Last Update Submit

May 9, 2018

Conditions

Keywords

dementiacognitive impairmentcognitionquality of lifedepressive symptomsReminiscence Therapy

Outcome Measures

Primary Outcomes (9)

  • Change from Baseline in the participant's Cognition

    Outcome Measure - Montreal Cognitive Assessment (MoCA)

    Intermediate assessment (week 7)

  • Change from Baseline in the participant's Cognition

    Outcome Measure - Montreal Cognitive Assessment (MoCA)

    Post-intervention assessment (week 14)

  • Change from Baseline in the participant's Cognition

    Outcome Measure - Montreal Cognitive Assessment (MoCA)

    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)

    Intermediate assessment (week 7)

  • Change from Baseline in the participant's Depressive Symptoms

    Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)

    Post-intervention assessment (week 14)

  • Change from Baseline in the participant's Depressive Symptoms

    Outcome Measure - Geriatric Depression Scale - 10 itens version (GDS-10)

    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)

    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)

    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)

    Five-week follow-up assessment (week 19)

Study Arms (2)

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.

Other: Reminiscence Therapy Program

Control Group

NO INTERVENTION

The control group shall participate in the institutional care provided by the professionals of each RSE.

Interventions

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.

Reminiscence Therapy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • present an unstable clinical condition;
  • do not wish to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Research Unit: Nursing

Coimbra, 3000-232, Portugal

Location

Related Publications (9)

  • 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.

    PMID: 19193252BACKGROUND
  • Directorate-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

    BACKGROUND
  • APA (213). Diagnostic and statistical manual of mental disorders (5th ed).(American Psychiatric Association, Ed.). Arlington.

    BACKGROUND
  • 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.

    PMID: 25040857BACKGROUND
  • Gibson, F. (2004). The past in the present: Using reminisce in health and social care. Baltimore: Health Professions Press.

    BACKGROUND
  • 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.

    PMID: 16855036BACKGROUND
  • Siverová, 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Cognitive DysfunctionDementiaDepression

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehavior

Study Officials

  • João LA Apóstolo, PhD

    Nursing School of Coimbra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Coordenador

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 12, 2017

Study Start

September 1, 2017

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations