Impact of the HELPeN Program on Social Isolation in Community-dwelling Elders (HELPeN)

NCT05644288 | Unknown

• 1 other identifier: PI21/00984
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective is to determine the effectiveness of the HELPeN Program, a 12-month telephone telenursing program for community-dwelling elderly in social isolation, evaluating the main changes in levels of social isolation, loneliness, quality of life, mental health status (depression), sleep and functional capacity, as well as changes in care management (demand for services and consumption of drugs). Methodology Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 6, 9 and 12 months. Participating subjects will be selected by nursing professionals from users of Area 3 of Health of the Region of Murcia over 65 years old, residing in the community and with a Social Isolation score \<32 (Low perceived social support with DUFSS). Randomization will be performed after stratification according to whether the subjects live alone or accompanied, with a 1:1 ratio. Given an alpha level of 0.05, an anticipated effect size of 1.58, beta power equal to 1, 42 subjects are required in each group. The intervention consists of a telephonic telenursing program HELPeN (Help eNursing) to be carried out in collaboration with the Poncemar Volunteer Bank. The control group will not receive any intervention.

Conditions

Loneliness; Isolation, Social

Keywords

Loneliness; Isolation, Social; Elderly people; Telenursing; Volunteers

Outcome Measures

Primary Outcomes (2)

• Loneliness

  Name of the measurement: Loneliness Definition: Loneliness is the result of a cognitive evaluation where there are discrepancies between the social relationships that people desire and those that they really have. Measuremente tool: UCLA Loniness Scale. Developed by psychologist Daniel Russell (1996), the UCLA Loneliness Scale (Version 3) is a 20-item measure that assesses how often a person feels disconnected from others. Unit of measure: Indicence of loneliness

  9 months

• Social isolation

  Name of the measurement: Social isolation Definition: Disengagement from social relationships, connections with institutions or community involvement. Measurement tool: DUKE-UNC Functional Social Support questionnaire(DUFSS). A 14-item, self-administered, multidimensional, functional social support questionnaire. Unit of measure: Incidence of social isolation

  9 months

Secondary Outcomes (7)

• Phisycal function

  9 months

• Depression

  9 months

• Mental status

  9 months

• Anxiety

  9 months

• Health Related Quality of life

  9 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The proposed intervention is a telephonic telenursing program aimed at managing social isolation in the elderly, the HELPeN (Help eNursing) program. The operational part of the intervention will be carried out by volunteers nursing students from the University of Murcia enrolled in the academic years 2020-2023. To ensure homogeneity in the intervention carried out by the volunteers they will receive a 15-hour training oriented to ensure the acquisition of essential communication skills for the implementation of the intervention and to know the specific interventions of support and counseling for the elderly in social isolation.

Other: Help eNursing

Control group

NO INTERVENTION

No intervention will be performed in the control group and the subjects will be contacted on the same dates as the intervention group for data collection.

Interventions

Help eNursing OTHER

The proposed intervention is a telephonic telenursing program aimed at managing social isolation in the elderly, the HELPeN (Help eNursing) program. The operational part of the intervention will be carried out by volunteers nursing students from the University of Murcia enrolled in the academic years 2020-2023. To ensure homogeneity in the intervention carried out by the volunteers they will receive a 15-hour training oriented to ensure the acquisition of essential communication skills for the implementation of the intervention and to know the specific interventions of support and counseling for the elderly in social isolation. Over the 36 weeks of the HELPeN Program, each volunteer is expected to provide intervention to 2 seniors, making 1 call per week to each subject lasting approximately 30 minutes. Students will perform physical and psychosocial assessments of the elders and create individualized care plans based on each subject's needs.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• score \< 32 (Low perceived social support with the DUFSS scale)
• Residence in the community

You may not qualify if:

• Severe cognitive impairment (8-10 errors on the Pfeiffer test)
• Non Spanish speakers
• Failure to consent to the study

Sponsors & Collaborators

• MARIA RUZAFA MARTINEZ: lead
• Instituto de Salud Carlos III: collaborator
• Fundación Poncemar: collaborator

Study Sites (1)

Healthcare Area III. Region of Murcia

Lorca, Murcia, 30817, Spain

RECRUITING

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• César Leal-Costa, RN, PhD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

• María Ruzafa-Martínez, RN, PhD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María J Hernández-López, RN, MsC

CONTACT

+34 968489191; mariaj.hernandez34@carm.es

Solanger Hernández-Méndez, RN, PhD

CONTACT

+34968445792; solanger.hernandez@carm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data will be collected by three team members who will make a telephone call to the study participants and record the study variables on four occasions throughout the study. They will be blinded, i.e., they will have no information about the major. Also, the data analyst will not know to which group each subject belongs.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor. Faculty of Nursing. University of Murcia

Model Details: Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 9 and 12 months.

Study Record Dates

• First Submitted: November 26, 2022
• First Posted: December 9, 2022
• Study Start: December 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 9, 2022

Record last verified: 2022-12

Locations

ES (1)