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LonelinessINOSELNCT03695133

Nursing Care Interventions According to Integrative Nursing and Omaha System in Elderly Women Feeling Loneliness

A study testing Group-based interventions in people with Loneliness, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Loneliness
What is being tested?
Group-based interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2018to 15 May 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
  • Women only
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Akdeniz University

    Antalya, 07058

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Nursing Care Interventions According to Integrative Nursing and Omaha System in Elderly Women Feeling Loneliness: Study Protocol for a Randomized Controlled Trial

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.

Conditions
Loneliness
Being tested
Group-based interventions
Keywords
loneliness, elderly, integrative nursing, omaha system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group-based interventionsBehavioural

    Also called individual 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.
Study groups in NCT03695133
Study groupRoleWhat they receive
intervention groupExperimental1. 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.
Receives: Behavioral: Group-based interventions
control groupNo interventionThe control group will not take any intervention, the post-tests will be collected at the end of 12 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (6)

  1. International Physical Activity Questionnaire

    There are 7 questions in the short form of the questionnaire. This measure assesses the types of intensity of physical activity. The items in the short form were structured to provide separate scores on walking, moderate-intensity and vigorous-intensity activity. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities. Standard MET values for activities were established. Total Work MET-minutes/week =sum of Walking+Moderate+Vigorous MET-minutes/week scores at work. The score obtained is classified as non-physical activity (MET-600 energy level), insufficient physical activity level (MET = energy level between 600-3000) and adequate physical activity level (MET ≥ 3000 energy level).

    Measured: 12 weeks

  2. Health Status Perception Scale

    In order to determine the perception of health status, it is questioned how the individual evaluates his / her health now. Very good (1), good (2), bad (3) and very bad (4) options on the scale, the lowest score is 4, the highest score is 1.

    Measured: 12 weeks

  3. Social Inclusion Scale

    Social inclusion scale evaluates that whether having the opportunities and resources to participate fully in economic, social and cultural life and to enjoy a standard of wellbeing that is considered normal in the society in which we live or not. There are three subscales in the Lİkert type scale, consisting of 18 items: Social Isolation, Social Relations and Social Acceptance. The lowest score is 1 and the highest score is 72. As the score obtained from the scale increases, social inclusion is increasing.

    Measured: 12 weeks

  4. Multidimensional Scale of Perceived Social Support

    There are 12 items on the scale evaluating the adequacy of social support. In this scale, there are three sub-dimensions: family, friend and special human support. The sum of the obtained scores is collected separately for each subgroup and the sum of these groups gives the total score of the scale. The lowest score is 4 and the highest score is 28 from subscales. The lowest score is 12 and the highest score is 84 from total scale. The higher the score, the higher the perceived social support.

    Measured: 12 weeks

  5. Well-being Index

    This index evaluates the general emotional state. There are five items in the six-point likert type index. Questions that ask individuals how they often feel in the last two weeks are scored from 0 to 5. In this index, the points taken from the questions are collected and multiplied by four to 0-100 points. As the score from the index increases, it means that the emotional situation is good.

    Measured: 12 weeks

  6. Healthy Life Style Behavior Scale II (spiritual development sub-scale)

    It was developed to measure health promotion behaviors of individuals. The scale consists of 52 items and six factors (health responsibility, physical activity, nutrition, spiritual development, interpersonal relations and stress management). In this study, spiritual development subscale was used. Likert type scale is scored from 1 to 4. The lowest nine scores from the spiritual development subscale and the highest 36 points are taken. Increasing the score from the scale indicates that the spiritual development is good.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2018
  2. Study start1 Jan 2018
  3. Primary completion28 Feb 2018
  4. Study completion15 May 2018

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03695133
Sponsor's protocol ID
001
Acronym
INOSEL
Status last verified
May 2022
First submitted
2 Oct 2018
Last updated
10 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: I want to share a study protocol with other researchers.

Publications

  • 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.

    PubMed 37759148

Questions about this trial

What is this clinical trial studying?

A study testing Group-based interventions in people with Loneliness, run by Akdeniz University at 1 site in Turkey (Türkiye).

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 10 May 2022. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Loneliness Scale for the Elderly (time frame: 12 weeks). 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 NCT03695133, which also lists 1 linked publication.

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 10 May 2022.

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