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

MARIA RUZAFA MARTINEZ

Status: Enrolling

Conditions: Loneliness; Isolation, Social

Treatments: Other: Help eNursing

Study type: Interventional

Funder types: Other

Identifiers

NCT05644288

PI21/00984

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Help eNursing

Control group

No Intervention group

Description:

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.