NCT02965937

Brief Summary

The study aim is to evaluate the effectiveness of Story-Centred Care Intervention Program on reducing depressive symptoms, improving cognitive function, HRV, Blood pressure and quality of life in older adults living in a long-term care facility.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable depression

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

January 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

November 10, 2016

Last Update Submit

November 14, 2016

Conditions

Depression

Keywords

Attentively embracing storystory-centred careheart rate variabilitycognitive function

Outcome Measures

Primary Outcomes (1)

  • 15-Item Geriatric Depression Scale

    Change from depressive symptoms at 4 months

Secondary Outcomes (4)

  • The Short Portable Mental Status Questionnaire

    Change from cognitive at 4 months

  • blood pressure

    Change from blood pressure at 4 months

  • Heart rate variability

    Change from HRV at 4 months

  • WHO quality of life-BREF

    Change from quality of life at 4 months

Study Arms (2)

Story-Centred Care Intervention Program

EXPERIMENTAL

A theory-guided approach that emphasises a health-promoting potential of nurse-person dialogue about a health challenge.Participants randomised to the IG will be made to participate in a 4-week long story-centred care intervention program conducted by a trained researcher.

Other: Story-centred care intervention program

Health consultation control condition

ACTIVE COMPARATOR

Participants randomised to the control group will receive a health consultation from a trained researcher once a week for 4 weeks. The health consultation will be tailored to the participants' needs. Based on a previous study, the health consultation will include pain management, healthy nutrition, how to make best use of medical services and education and counselling for individual health-related concerns.

Other: Health consultation control condition

Interventions

Story-centred care intervention programOTHER

Participants in the intervention group received the "Story-Centred Care Intervention Program" once a week for four weeks.

Story-Centred Care Intervention Program
Health consultation control conditionOTHER

The control group received a health consultation from researchers once a week for four weeks.. The health consultation will be tailored to the participants' needs. Based on a previous study12, the health consultation will include pain management, healthy nutrition, how to make best use of medical services and education and counselling for individual health-related concerns.

Health consultation control condition

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- those who are ≥65 years old and live in long-term care facilities
  • \- have clear consciousness and normal hearing and conversation capability
  • \- are not taking any antidepressants at the time of the study
  • \- are not clinically diagnosed with dementia or have an SPMSQ score of ≥5
  • \- have not lost a loved one in the past 3 months and

You may not qualify if:

  • meet DSM-IV criteria for Dementia of the Alzheimer's type
  • suffer from moderate to severe cognitive impairment (SPMSQ \> 5)
  • are taking antidepressants at the time of the study
  • are undergoing other psychotherapy during the study and
  • have any underlying medical illness that could interfere with the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Kao Chi-Wen, PHD

    Taiwan Nurses Association

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Obstetrics and Gynecology, Clinical Professor

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 17, 2016

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

August 1, 2013

Last Updated

November 17, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share