NCT03695133

Brief Summary

Objectives: The present study investigates the effects of nursing care interventions on the physical, psychological, social and spiritual health of the elderly women with high level of loneliness according to the principles of integrative nursing and Omaha System. Methods: This study protocol describes a randomised controlled trial with to parallel group design. After the level of loneliness of elderly women will be determined by the Loneliness Scale for the Elderly in the Family Health Center, women with high levels of loneliness will be randomly assigned to the intervention and control group. Nursing care interventions consisting of group-based (sightseeing, picnics, theater, cinema) and individual according to Integrative Nursing and Omaha System. Elderly women who feel loneliness will continue for 12 weeks. Pre-tests and post-tests will be completed during home visits made by the researchers. Discussion: This study will provide evidence regarding the effectiveness of nursing care interventions that include the comprehensive (physical, psychological, social and spiritual) evaluation of their health, and contribute to provide care in terms of Integrative Nursing and Omaha System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

October 2, 2018

Last Update Submit

May 9, 2022

Conditions

Keywords

lonelinesselderlyintegrative nursingomaha system

Outcome Measures

Primary Outcomes (1)

  • Loneliness Scale for the Elderly

    The loneliness scale for the elderly was developed to determine the sense of loneliness. The two subscales in the scale are: emotional and social loneliness subscales. There are 11 items in the binary Likert type scale. Minumum and maximum scores are 0 and 22 points, respectively. The total score is obtained by collecting the scores from the subscales. Loneliness can be divided into four levels according to the score. "0-4 scores" do not feel loneliness, "5-14 scores" acceptable loneliness, "15-18 scores" feeling very loneliness and "19-22 scores" feeling very lonely. Levels increase the level of loneliness.

    12 weeks

Secondary Outcomes (6)

  • International Physical Activity Questionnaire

    12 weeks

  • Health Status Perception Scale

    12 weeks

  • Social Inclusion Scale

    12 weeks

  • Multidimensional Scale of Perceived Social Support

    12 weeks

  • Well-being Index

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

1. Group-based interventions Group-based interventions include physical activity, sightseeing, picnics, theater, cinema, group educations. 2. Individual interventions Individual interventions include interventions in the Omaha System Nursing Interventions Scheme that is specific to health problems of elderly women.

Behavioral: Group-based interventions

control group

NO INTERVENTION

The control group will not take any intervention, the post-tests will be collected at the end of 12 weeks.

Interventions

1. Group-based interventions Elderly women will have a walk for physical activity for 12 weeks, three days a week. It is planned that each of the sightseeing, picnic, theater and cinema activities will be done twice. The topics that elderly women need most for group educations will be determined. Group educations will be held once every four weeks approximately three hours. 2. Individual interventions After the pre-tests are applied to the women in the intervention group, the home environment and the individual's health problems will be assessed, interventions will be implemented and the results will be evaluated during home visits at online. During the home visit to the elderly women and twelve-week intervention period, each woman will meet four times and initiatives will be implemented.

Also known as: individual interventions
intervention group

Eligibility Criteria

Age65 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsto feel very lonely and very lonely according to the Loneliness Scale for the Elderly
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • to be independent according to the Katz Daily Activities Activity Scale;
  • no problem in physical activity with the suggestion of the doctor in Family Health Center;
  • living alone or with family;
  • good cognitive state (place, time and person orientation) with the suggestion of the doctor; - the willingness to participate in the study

You may not qualify if:

  • to live in any elderly care center or nursing home;
  • to be semi-dependent and dependent according to the Katz Daily Activities Activity Scale
  • to have a psychiatric disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07058, Turkey (Türkiye)

Location

Related Publications (1)

  • Ilgaz A, Gozum S. Effectiveness of INOSEL program consisting of Integrative Nursing and Omaha System for older women feeling loneliness: a randomised controlled trial. Aging Clin Exp Res. 2023 Nov;35(11):2769-2781. doi: 10.1007/s40520-023-02559-9. Epub 2023 Sep 28.

Study Officials

  • Ayşegül ILGAZ

    Research Assistant

    PRINCIPAL INVESTIGATOR

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
Research Assistant

Study Record Dates

First Submitted

October 2, 2018

First Posted

October 3, 2018

Study Start

January 1, 2018

Primary Completion

February 28, 2018

Study Completion

May 15, 2018

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
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Shared Documents
STUDY PROTOCOL
Time Frame
one year
More information

Locations