NCT02906306

Brief Summary

The objective of this study is to determine whether individual and/or group occupational therapy leads to changes in generalized self-efficacy and psychological well-being, and to identify the type of therapy that has the best effects on older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

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, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

September 7, 2016

Last Update Submit

January 30, 2017

Conditions

IndividualitySelf-EfficacyWell-being

Keywords

Older adultsOccupational TherapySelf-EfficacyPsychological Well-being

Outcome Measures

Primary Outcomes (5)

  • Ryff Questionnaire

    The scale of psychological well-being Ryff is formed by the complete version of 39 items with Likert responses it 1-6. The main objective this scale is to measure the degree of psychological well-being of personaa through 6 dimensions: purpose in life, self-acceptance, positive relationships, autonomy, environmental mastery and personal growth

    6 months

  • General Self-efficacy

    The scale of generalized self-efficacy is a self informed through 10 items with 1-4 Likert scale responses. The main objective is to measure the degree of generalized self-efficacy of the person across 10 assertions with 4 possible answers above, in which the option that best reflects what the person thinks is marked

    6 months

  • Barthel Index

    Barthel index measured through 10 items the level of dependence of the person performing the activities of daily life can vary between 0 (completely dependent) to 100 (completely independent)

    6 months

  • Minimental MMSS

    The MMSE is composed of 13 items to assess with scores (0,1,2,3,4,5) according answer. the main objective is to briefly assess the mental state and allow observe the degree of progression of cognitive status through the following areas: orientation, fixation, concentration and calculation, memory, language and construction.

    6 months

  • Geriatric Depression Scale (GDS)

    Geriatric Depression Scale consists of 15 items (10 negative and 5 positive) through answers (yes / no) whose content focuses on cognitive behavioral aspects related to special characteristics of the population. The main objective is to facilitate the assessment of depression in the geriatric population.

    6 MONTHS

Study Arms (2)

Individual Occupational therapy

EXPERIMENTAL

In Individual Occupational Therapy treatment the activities included personal independence training (ADLs), sensory-motor stimulation activities, cognitive stimulation (attention, memory, language and executive function) and animal-assisted therapy (AAT).

Behavioral: Individual Occupational Therapy

Group Occupational therapy

EXPERIMENTAL

In group Occupational Therapy treatment the activities included personal independence training (ADLs), sensory-motor stimulation activities, cognitive stimulation (attention, memory, language and executive function) and animal-assisted therapy (AAT) and psychosocial skills training.

Behavioral: Group Occupational Therapy

Interventions

Individual Occupational TherapyBEHAVIORAL

45 minutes 3 times per week 6 months in nursing homes (A and B)

Individual Occupational therapy
Group Occupational TherapyBEHAVIORAL

45 minutes 3 times per week 6 months in nursing homes (A and B)

Group Occupational therapy

Eligibility Criteria

Age78 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Be able to read
  • Have normal cognitive function scoring \>22 on Mini Mental Scale Examination
  • Sign informant consent
  • Apply the recommendations

You may not qualify if:

  • Advanced cognitive impairment
  • Fear of animals
  • Miss three time
  • Visual impairment
  • Multiple disorders
  • Hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaga

Málaga, Malaga, Spain

Location

Related Publications (1)

  • Toledano-Gonzalez A, Labajos-Manzanares T, Romero-Ayuso DM. Occupational Therapy, Self-Efficacy, Well-Being in Older Adults Living in Residential Care Facilities: A Randomized Clinical Trial. Front Psychol. 2018 Aug 7;9:1414. doi: 10.3389/fpsyg.2018.01414. eCollection 2018.

    PMID: 30131748DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapy

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 20, 2016

Study Start

September 1, 2014

Primary Completion

January 1, 2015

Study Completion

November 1, 2015

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

ES(1)