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

NCT05644288 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-12-09

No results posted yet for this study

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

Interventions

OTHER

Help eNursing

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.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV
  • Fundación Poncemar

    collaborator UNKNOWN
  • MARIA RUZAFA MARTINEZ

    lead OTHER

Principal Investigators

  • César Leal-Costa, RN, PhD · Universidad de Murcia

  • María Ruzafa-Martínez, RN, PhD · Universidad de Murcia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-05-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05644288 on ClinicalTrials.gov