Analysis of the symptoms and quality of life of people with a diagnosis of long COVID-19, and the effectiveness of an intervention in primary care using ICTs

Effectiveness and cost-effectiveness of a multimodal programme as coadjuvant treatment in people with a diagnosis of long COVID-19 from primary health care: a randomised clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91104012

Enrollment

Registered

2022-02-10

Start date

2022-03-01

Completion date

Unknown

Last updated

2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long COVID-19 Infections and Infestations

Interventions

Current intervention as of 11/03/2022: Patients allocated in the control group will follow the usual treatment provided by their GP (treatment as usual (TAU)). Patients allocated in the intervention

b) Sleep hygiene habits to improve the quality of sleep

c) Physical activity (type of physical exercise may be practiced, the intensity, how and when to do them).

d) Exercices of Cognitive stimulation to improve the cognitive deficits and e) Adherence to the Mediterranean diet to improve the intake of omega-3, B, and D vitamins

f) social activation and use of community resources. As the symptomatology is very varied, during the face-to-face sessions, the recommendations will be personalized, especially directing the interve

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 11/03/2022: 1. Individuals over the age of 18 years 2. Suffering from long COVID-19 3. From Primary Health Centers of Aragón (Spain) 4. Understand written and spoken Spanish 5. Have provided their informed consent 6. Who are not undergoing training or rehabilitation through respiratory physiotherapy, physical activity, or cognitive stimulation Previous participant inclusion criteria: 1. Individuals over the age of 18 years 2. Suffering from long COVID-19 3. From Primary Health Centers of Aragón (Spain) 4. Understand written and spoken Spanish 5. Have provided their informed consent

Exclusion criteria

Exclusion criteria: 1. Presence of serious uncontrolled medical illness, which may interfere with compliance with the activities and recommendations 2. Risk of suicide 3. Pregnancy or lactation 4. Patients who have participated in another clinical trial over the past 6 months 5. Are currently receiving structured psychotherapeutic treatment by a mental health professional over the past 6 months 6. The presence of any medical, psychological or social problem that could seriously interfere with the patient’s participation in the study

Design outcomes

Secondary

Measure	Time frame
Current secondary outcome measures as of 14/03/2022: 1. Cognitive status using Evaluación Cognitiva de Montreal (MoCA), Memory Impairment Screen (MIS), semantic fluency test and digits and symbols test. At baseline, 3 months, 6 moths and 12 months. 2. Respiratory status will be evaluated using 6 minutes walking test, 30-second chair stand test, and Borg scale at baseline, 3 months, 6 moths and 12 months. 3. Physical activity using IPAQ-SF at baseline, 3 months, 6 months and 12 months. 4. Adherence to mediterranean diet using MEDAS at baseline, 3 months, 6 months and 12 months. 5. Quality and patterns of sleep using Insomnia Severity Index at baseline, 3 months, 6 months and 12 months. 6. Depression and anxiety using HADS at baseline, 3 months, 6 months and 12 months. 7. Social support using MOS at baseline, 3 months, 6 months and 12 months. 8. Self-efficacy using self-efficacy scale at baseline, 3 months, 6 months and 12 months. 9. Patient activation in their own health using the PAM at baseline, 3 months, 6 months and 12 months. 10. Use of health and social services measured using the Client Service Receipt Inventory at baseline, 3 months, 6 months and 12 months. Previous secondary outcome measures as of 11/03/2022: 1. Cognitive status using Evaluación Cognitiva de Montreal (MoCA), Memory Impairment Screen (MIS), semantic fluency test and digits and symbols test. At baseline, 3 months, 6 moths and 12 months. 2. Respiratory status will be evaluated using 6 minutes walking test, 30-second chair stand test, and Borg scale at baseline, 3 months, 6 moths and 12 months. 3. Physical activity using IPAQ-SF at baseline, 3 months, 6 months and 12 months. 4. Adherence to mediterranean diet using MEDAS at baseline, 3 months, 6 months and 12 months. 5. Quality and patterns of sleep using Insomnia Severity Index at baseline, 3 months, 6 months and 12 months. 6. Depression and anxiety using HADS at baseline, 3 months, 6 months and 12 months. 7. Self-efficacy using	—

Measure

Time frame

Current secondary outcome measures as of 14/03/2022: 1. Cognitive status using Evaluación Cognitiva de Montreal (MoCA), Memory Impairment Screen (MIS), semantic fluency test and digits and symbols test. At baseline, 3 months, 6 moths and 12 months. 2. Respiratory status will be evaluated using 6 minutes walking test, 30-second chair stand test, and Borg scale at baseline, 3 months, 6 moths and 12 months. 3. Physical activity using IPAQ-SF at baseline, 3 months, 6 months and 12 months. 4. Adherence to mediterranean diet using MEDAS at baseline, 3 months, 6 months and 12 months. 5. Quality and patterns of sleep using Insomnia Severity Index at baseline, 3 months, 6 months and 12 months. 6. Depression and anxiety using HADS at baseline, 3 months, 6 months and 12 months. 7. Social support using MOS at baseline, 3 months, 6 months and 12 months. 8. Self-efficacy using self-efficacy scale at baseline, 3 months, 6 months and 12 months. 9. Patient activation in their own health using the PAM at baseline, 3 months, 6 months and 12 months. 10. Use of health and social services measured using the Client Service Receipt Inventory at baseline, 3 months, 6 months and 12 months. Previous secondary outcome measures as of 11/03/2022: 1. Cognitive status using Evaluación Cognitiva de Montreal (MoCA), Memory Impairment Screen (MIS), semantic fluency test and digits and symbols test. At baseline, 3 months, 6 moths and 12 months. 2. Respiratory status will be evaluated using 6 minutes walking test, 30-second chair stand test, and Borg scale at baseline, 3 months, 6 moths and 12 months. 3. Physical activity using IPAQ-SF at baseline, 3 months, 6 months and 12 months. 4. Adherence to mediterranean diet using MEDAS at baseline, 3 months, 6 months and 12 months. 5. Quality and patterns of sleep using Insomnia Severity Index at baseline, 3 months, 6 months and 12 months. 6. Depression and anxiety using HADS at baseline, 3 months, 6 months and 12 months. 7. Self-efficacy using

—

Primary

Measure	Time frame
Quality of life using SF-36 at baseline, 3 months, 6 moths and 12 months.	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 16, 2026