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Completed

NCT Number: NCT04225845

The Economic Consequences of Loneliness Among the Elderly

Elderly individuals across the world are increasingly living alone. However, little is known about the effects of loneliness on economic and health outcomes. The elderly living alone (i.e., in a household of size 1) will be randomized into one of two cross-randomized intervention arms or a control condition to improve older individuals' mental wellbeing as well as ability to cover basic needs, particularly in times of COVID (including health). The first intervention will focus on improving the elderly's outlook on life and relationships through problem-solving therapy (PST) delivered over the phone. The second will deliver to them a one-time cash transfer of Rs.1000, equivalent to the emergency help amount distributed to ration card holder by the government of Tamil Nadu. Each intervention will be offered on its own in each of two treatment arms, and in combination in a third. A control group will receive no intervention. Investigators will track outcomes of the elderly at 3 weeks and 3 months after the intervention.

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Key information

Conditions

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JPAL SA at IFMR

Chennai, Tamil Nadu, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 55 years of age
  • Individuals living alone

Exclusion criteria

-

Treatment and study plan

Phone therapy

Behavioral

Weekly phone calls by lay trained personnel to deliver problem solving therapy.

Cash Transfer

Behavioral

One-time cash transfer of Rs.1000.

Primary outcomes

  1. Difficulty in performing daily activities/Functional impairment score

    Time frame: Assessed at 3 weeks after intervention

    Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, doing day-to-day work, dealing with people they do not know, maintaining a friendship, being emotionally affected by health problems, and joining in community activities. The scale is from 0-4, with 0 being no difficulty, 1 mild, 2 moderate, 3 severe, and 4 cannot do. The scores will be summed to create a cumulative score on a 0-48 scale.

  2. Difficulty in performing daily activities/Functional impairment score

    Time frame: Assessed at 3 months after intervention

    Participants will be asked the level of difficulty they have in doing each of the following tasks: standing for 30 minutes, walking a long distance (1km), concentrating for 10 minutes, learning a new task like getting to a new place, washing whole body, getting dressed, taking care of household activities, doing day-to-day work, dealing with people they do not know, maintaining a friendship, being emotionally affected by health problems, and joining in community activities. The scale is from 0-4, with 0 being no difficulty, 1 mild, 2 moderate, 3 severe, and 4 cannot do. The scores will be summed to create a cumulative score on a 0-48 scale.

  3. Mental health

    Time frame: Assessed at 3 weeks after intervention

    The geriatric depression index short form is used. Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, afraid that something bad is going to happen to them, feel happy most of the time, often feel hopeless, prefer to stay at home, rather than going out and doing new things, have problems with memory, think it is wonderful to be alive, feel worthless, feel full of energy, feel lonely, feel their situation is hopeless, think that most people are better off than they are. Responses will be summed over these questions.

  4. Mental health

    Time frame: Assessed at 3 months after intervention

    The geriatric depression index short form is used. Participants are asked yes/no questions: if they are satisfied with their lives, have dropped activities and interests, feel their life is empty, often get bored, in good spirits most of the time, afraid that something bad is going to happen to them, feel happy most of the time, often feel hopeless, prefer to stay at home, rather than going out and doing new things, have problems with memory, think it is wonderful to be alive, feel worthless, feel full of energy, feel lonely, feel their situation is hopeless, think that most people are better off than they are. Responses will be summed over these questions.

  5. Food security

    Time frame: Assessed at 3 weeks after intervention

    Participants will be asked to report whether in the past week they had to skip or cut the size of meals in the past week.

  6. Food security

    Time frame: Assessed at 3 months after intervention

    Participants will be asked to report whether in the past week they had to skip or cut the size of meals in the past week.

Secondary outcomes

  1. Seeking or receiving COVID vaccine

    Time frame: Assessed at 3 weeks after intervention

    Participants will be asked if they received the COVID vaccine or sought it (went to the health center but there was no availability).

  2. Seeking or receiving COVID vaccine

    Time frame: Assessed at 3 months after intervention

    Participants will be asked if they received the COVID vaccine or sought it (went to the health center but there was no availability).

  3. Loneliness

    Time frame: Assessed at 3 weeks after intervention

    Measured using the short-form University of California, Los Angeles (UCLA) Loneliness Scale (aka ULS-4). This is a 4-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The questions are: no one really knows me well, people are around me but not with me, I feel in tune with the people around me, I can find companionship when I want it. Subjects rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Responses are summed over the four questions and rescaled to a 0-1 scale.

  4. Loneliness

    Time frame: Assessed at 3 months after intervention

    Measured using the short-form University of California, Los Angeles (UCLA) Loneliness Scale (aka ULS-4). This is a 4-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The questions are: no one really knows me well, people are around me but not with me, I feel in tune with the people around me, I can find companionship when I want it. Subjects rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Responses are summed over the four questions and rescaled to a 0-1 scale.

  5. Healthcare utilization

    Time frame: Assessed at 3 weeks after intervention

    Participants will be asked if they fell ill in the last week, and, if yes, whether they used a medical provider or pharmacy to deal with the illness (0/1).

  6. Healthcare utilization

    Time frame: Assessed at 3 months after intervention

    Participants will be asked if they fell ill in the last week, and, if yes, whether they used a medical provider or pharmacy to deal with the illness (0/1).

  7. Survival of elderly person

    Time frame: Assessed at 3 weeks after intervention

    Whether still living at time of follow-up survey (0/1 variable)

  8. Survival of elderly person

    Time frame: Assessed at 3 months after intervention

    Whether still living at time of follow-up survey (0/1 variable)

  9. Social integration: non-family

    Time frame: Assessed at 3 weeks after intervention

    This is an indicator for whether the participant talked on the phone with anyone (with the exception of children and grandchildren) in the past week (0/1 scale).

  10. Social integration: non-family

    Time frame: Assessed at 3 months after intervention

    This is an indicator for whether the participant talked on the phone with anyone (with the exception of children and grandchildren) in the past week (0/1 scale).

  11. Social integration: family

    Time frame: Assessed at 3 weeks after intervention

    This is an indicator for whether the participant talked on the phone with children or grandchildren in the past week (0/1 scale).

  12. Social integration: family

    Time frame: Assessed at 3 months after intervention

    This is an indicator for whether the participant talked on the phone with children or grandchildren in the past week (0/1 scale).

  13. Cognitive function

    Time frame: Assessed at 3 weeks after intervention

    Participants will be administered the mini mental state exam, scored on a 0-11 scale, rescaled to a 0-1 scale.

  14. Cognitive function

    Time frame: Assessed at 3 months after intervention

    Participants will be administered the mini mental state exam, scored on a 0-11 scale, rescaled to a 0-1 scale.

  15. Consumption

    Time frame: Assessed at 3 weeks after intervention

    Participants will be asked, for the last week, amount spent on different food items (rice, wheat, pulses, milk, spices, sugar, oil, meats, vegetables, fruits, packaged foods), medical expenses, fuel, clothing, footwear, toiletries, transportation, gifts, jewelry, and other expenses.

  16. Consumption

    Time frame: Assessed at 3 months after intervention

    Participants will be asked, for the last week, amount spent on different food items (rice, wheat, pulses, milk, spices, sugar, oil, meats, vegetables, fruits, packaged foods), medical expenses, fuel, clothing, footwear, toiletries, transportation, gifts, jewelry, and other expenses.

  17. Health

    Time frame: Assessed at 3 weeks after intervention

    This is a 16-point score comprised of indicators for whether the respondent faced health issues in the last week, according to the question, Did you face any health issues in the past week?, and then a follow-up in which the participant specified which health issues they faced. For each of the following (unprompted) issues they faced, one point was added to their score: cold/runny nose/cough/sore throat, fever, diabetes/hypertension, excessive fatigue, dizziness, earache, chills/shivering, diarrhoea, vomiting, bloody stool/urine, body/joint pain, fall/injury, acute emergency, breathlessness, vision/hearing/skin problems, other. Those who reported no health issues were given a score of zero.

  18. Health

    Time frame: Assessed at 3 months after intervention

    This is a 16-point score comprised of indicators for whether the respondent faced health issues in the last week, according to the question, Did you face any health issues in the past week?, and then a follow-up in which the participant specified which health issues they faced. For each of the following (unprompted) issues they faced, one point was added to their score: cold/runny nose/cough/sore throat, fever, diabetes/hypertension, excessive fatigue, dizziness, earache, chills/shivering, diarrhoea, vomiting, bloody stool/urine, body/joint pain, fall/injury, acute emergency, breathlessness, vision/hearing/skin problems, other. Those who reported no health issues were given a score of zero.

Sponsors and collaborators

Lead sponsor

National Bureau of Economic Research, Inc.

Other

Collaborators

  • Abdul Latif Jameel Poverty Action Lab
  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 13, 2020
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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