Self-management, Health Literacy and Social Capital in Socioeconomically Disadvantaged Older Adults (AEQUALIS)

February 6, 2018 updated by: Laura Coll, Fundacio Salut i Envelliment UAB

Promoting Self-Management, Health Literacy And Social Capital In Socioeconomically Disadvantaged Older Adults To Reduce Later Life Health Inequalities: A Randomized Clinical Trial

Motivations:

Socio-economic and education determinants have a big impact on health outcomes, in terms of worse health status in populations living in more disadvantaged conditions. Social capital, self-management and health literacy are some of the intermediate determinants, with the potential to mitigate health inequalities through interventions driven by local health agents. These three determinants are intensely interlinked and have, separately, impacts on self-perceived health. Social capital is defined in this project as an umbrella concept, which includes quantitative aspects of social resources (structural social capital: social networks and contacts, social and civic participation) as well as qualitative or subjective aspects (cognitive social capital: perceived social support, feeling of belonging and trust) and covers relations between subjects at a micro or individual level (family and friends) as well as at a macro or community level. Health literacy is understood as cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. Both are key aspects for self-management behaviours. The target of our research project are older people living in urban socioeconomically disadvantaged areas, since ageing is in itself an inequality axis and urban environments concentrate the highest health disparities.

Objectives: With the aim to reduce health inequality, an intervention has been designed to promote self-management, health literacy and social capital among older people who perceived their health as fair or poor and are living in urban socioeconomically disadvantaged areas with the aim of improving their self-perceived health. Secondarily, the efficacy of the intervention will be analysed in terms of increasing self-management, health literacy and social capital (social support and social participation), quality of life, mental health and healthy lifestyles.

In third place, behavioural health patterns will be identified in relation to health literacy, social capital, gender, socioeconomic and educational level, and they will be linked to the intervention efficacy levels.

Study Overview

Study Type

Interventional

Enrollment (Actual)

390

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • community-dwelling older adults living in the urban areas of Barcelona, Blanes or Reus in socio-economically disadvantaged neighbourhoods.
  • perception of their health as regular or bad according to the first question of the 12 items Short Form Survey from the RAND Medical Outcomes Study.

Exclusion Criteria:

  • dependency to go to the local primary care center
  • cognitive decline or dementia as diagnose
  • any health condition that contraindicates physical activity
  • terminal illness
  • severe mental health disorders that difficult participating in a group dynamic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Program "Sentirnos bien"

The intervention Program "Sentirnos bien" is based around a group dynamic, held once a week during 3 months, aimed at:

  1. Promoting the uptake of self-care healthy habits
  2. Promoting social capital at individual level:
  3. Promoting health literacy

Group-based intervention delivered face-to face and held once a week during 3 months. It comprises:

  1. Promoting the uptake of self-care healthy habits: providing information, setting personal goals and sharing experiences to facilitate behavioural change, specially on physical activity and healthy dietary habits.
  2. Promoting social capital at individual level: facilitating mutual knowledge and mutual support among participants and fostering participation in sociocultural and community activities in the neighbourhood through visits to the community assets accompanied by volunteers.
  3. Promoting health literacy: improving navigation through the health care system, communication with health professionals, as well as the understanding and decision making when buying food.
NO_INTERVENTION: Control arm
The control arm will receive no intervention. Once the trial is finished, i.e. after the last follow-up evaluation, this arm will receive the intervention (waiting-list approach).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-perceived health
Time Frame: at 3 months (just after the intervention)
Same question than the 12 items Short Form Survey from the RAND Medical Outcomes Study. Answers will be recategorized as positive perception (excellent, very good or good) vs negative (regular or bad)
at 3 months (just after the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-perceived health
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Thermometer from 0-100
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Health related quality of life
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
12 items Short Form Survey from the RAND Medical Outcomes Study.
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Self-rated quality of life
Time Frame: t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Thermometer from 0-100
t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Loneliness
Time Frame: t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Scale Gierveld and De Jong
t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Depressive symptoms
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Geriatric Depression Scale
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Physical activity
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
International Physical Activity Questionnaire (IPAQ)
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Short Physical Performance Battery
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Functional test that scores performance in three physical aspects: balance, strength and gait speed.
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Health service use
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Times attending primary and hospital health care
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Unintended effects
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Questions ad hoc to assess effects not intended by the intervention perceived negatively by the participant.
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Self-care / healthy habits
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Scale ASA (Appraisal of Self-Care Agency Scale)
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Health literacy
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
questions from the European Health Literacy Scale (HLS EU-16)
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Social capital
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
2 questions from the European Values Survey
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Social support
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Questionnaire "Inventario de recursos sociales en ancianos" from Díaz Veiga
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Social participation
Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Questionnaire "Escala Este II de Soledad - Índice de participación social subjetiva"
at month 3 (just after the intervention) and at month 12 (9 months after the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laura Coll-Planas, MD, Fundacio Salut i Envelliment UAB
  • Principal Investigator: Sergi Blancafort, PhD, Fundacio Salut i Envelliment UAB
  • Principal Investigator: Rosa Monteserin, MD PhD, Equipo Atencio Primaria Sardenya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • FSIE-Recercaixa2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Program "Sentirnos bien" (Feeling well)

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